Urgent Device Correction
Contents
1. Users of COLLEAGUE pumps should be aware that if the pump s batteries are not charged continuously for 12 hours after a Battery Low alert or Battery Depleted alarm occurs the remaining operating time after a subsequent Battery Low alert can be less than 30 minutes This will be followed by a Battery Depleted alarm with both an audible and visual notification and the infusion s will stop In order to restart the infusion s users must plug the pump into a power outlet immediately In order to avoid the possibility of interruption or cessation of therapy loss of configuration memory and or device failure it is important that you follow the charging instructions listed in the Operators Manual prior to using the pump under battery operation Please also refer to the Battery Usage Guide Attachment 1 for additional information on proper battery usage and maintenance COLLEAGUE and Baxter are registered trademarks of Baxter International nc 2005 072 MN Baxter Generation of False Air Detected Alarm due to IV Administration Set Tugging Baxter has received one report of a patient death that may be associated with an interruption of therapy due to a false Air Detected alarm Pulling or tugging on the IV administration set between the pump channel and the patient may cause a false Air Detected alarm which will cause the pump to stop infusing and issue an audible and visual notification In order to reduce the potential for this sit2. Never insert tools or other objects into the tubing channel when attempting to load or unload the administration set Never use the Manual Tube Release to load or unload the administration set during normal operation If the above instructions are not followed there is a potential for misaligning the pump chamber components which may result in an under delivery condition Upstream Occlusion Detection The pump may not detect an upstream occlusion if one or more of the following conditions exist e Use of a source container which has had all air removed e Incomplete insertion of the spike into the source container Improper venting of a ngid glass bottle or semi rigid plastic container including Buretrols If using rigid non vented containers refer to the appropriate administration set instructions to determine the correct venting procedure e The air vent above the burette chamber is not open To help ensure upstream occlusions are detected by the pump do not invert the set and squeeze fluid back into the primary container Doing this may wet out the vent filter and obstruct airflow Fluid Getting into the Pumping Channel Do not allow fluid to enter the tubing channel Contact your Baxter Service Center for assistance immediately if fluid enters the tubing channel The tubing channel should be cleaned as soon as possible by Baxter trained qualified personnel to minimize potential difficulties caused by fluid pooling an
3. including Area Code We understand the contents of the letter performed the actions as outlined in the letter as needed and have disseminated this information to our staff other services facilities customers as applicable Signature Date REQUIRED FIELD COLLEAGUE and Baxter are registered trademarks of Baxter International Inc 2005 072 MD te se E B me Ye Bm ar paoe Colleague Rete OR T EA E T ae Ser g mas ae Gar Se se we pS an Jen Pana PnP aS AP lt _ oar PAS E Bake SE Tw Thu SS P t J fi t Battery Usage Guide It is imperative that institutions have a contingency plan to mitigate any disruptions of infusions of life sustaining drugs The Interruption or delay of life sustaining therapy may result in potential injury or death You should consider not using these pumps in situations where a replacement pump is not available or where an interruption in therapy may be life threatening Before initially powering on the pump charge the battery for at least 12 uninterrupted hours A complete charge may take longer than 12 hours The Battery Charge Level Indicator will overstate the remaining battery charge level and operating time after a Battery Low alert can be significantly less than expected if the pump s batteries are subjected to any of the following conditions e Failure to recharge the batteries for at least 12 uninterrupted hours after occurrence of a Battery Low alert or a Batter
4. to COLLEAGUE Important Product Information Letter Dated 12 13 05 Baxter Healthcare Corporation Route 120 amp Wilson Road aren URGENT DEVICE CORRECTION Baxter lt D PAR March 17 2005 RE BURETROL R SOLUTION SET 150ML BURETTE BALL VALVE Product Code 2C7546 S and INTERLINK BURETROL SOLUTION SET 150ML BURETTE BALL VALVE Product Code 2C7566 S Dear Director of Nursing Baxter Healthcare Corporation is providing you with important information conceming the Buretrol sets listed above These specific BURETROL Sets are currently labeled as acceptable for use with the COLLEAGUE Volumetric Infusion Pump refer to S suffix following product code When these sets are used with the COLLEAGUE pump there is a potential for a non detection of an upstream occlusion under certain conditions As a result of this information we do not recommend product codes 2C7546 S and 2C7566 S for use with the COLLEAGUE Volumetric Infusion pumps Alternative product codes 2C7519 S and 2C7564 S are compatible sets that can be used with the COLLEAGUE Volumetric Infusion pump If you have any questions concerning the compabbility of other BURETROL Sets with the COLLEAGUE Volumetric Infusion Pump please contact Baxter Medication Delivery Product Information Center at 1 800 933 0303 Piease complete the attached reply form confirming your receipt of this letter and fax it to Baxter using either fax number provided on the form Returning the for
5. Baxter Healthcare Route 120 amp Wilson Road Round Lake illinois 60073 0490 URGENT DEVICE Baxter CORRECTION December 13 2005 Re COLLEAGUE VOLUMETRIC INFUSION PUMP PRODUCT CODES 2M8151 amp 2M81 o1R COLLEAGUE 3 VOLUMETRIC INFUSION PUMP PRODUCT CODES 2M8153 amp 2M8153R COLLEAGUE CX VOLUMETRIC INFUSION PUMP PRODUCT CODES 2M8161 amp 2M8161 R COLLEAGUE 3 CX VOLUMETRIC INFUSION PUMP PRODUCT CODES 2M8163 amp 2M8163R Dear Director of Nursing Baxter Healthcare Corporation is sending this communication to notify you of an Urgent Device Correction related to the COLLEAGUE Volumetric Infusion Pump During the investigation into resolution of issues previously communicated to customers Baxter has identified additional issues that we want to bring to your attention These issues fall into the following categories Battery Undercharging Generation of False Air Detected Alarm due to IV Administration Set Tugging Gearbox Wear Underinfusion Non Detection of Upstream Occlusion Additional information to help users avoid conditions that may interrupt therapy along with other guidance on the usage of your COLLEAGUE pump is described in the Battery Usage Guide Attachment 1 and Infusion Management Guide Attachment 2 These attachments should be provided to all users of the COLLEAGUE pump Battery Undercharging Baxter has received one report of a patient death that may be associated with an undercharged battery
6. and the pump to reduce tugging on the set 3 Lastly ensure there is sufficient slack in the tubing between the distal end of the pumping channel and the patient to prevent tube tugging during activities such as moving the patient from one bed to another or transportation of the patient from one facility location to another Conditions That May Affect Pump Delivery Accuracy Note that flow fluctuations can be caused by unusual conditions or combinations of conditions that may involve but are not limited to the following Position of the infusion container Fluid density Positive and negative pressure The environment Flow fluctuations are most likely to occur when the conditions mentioned above are exacerbated or when the pump is operated in conditions outside of its normal limits While the Colleague pump automatically closes the keyed slide clamp always manually close the regulating clamp on the administration set before removing the set from the pump Loading the IV Administration Set see the following instructions for proper loading of the IV Administration set When loading the IV set pull the administration set taut and slide it all the way into and along the tubing channel Figure C and D The pump pulls in the keyed slide clamp then loads the administration set into the pumping mechanism The pump module displays LOADING and then STOPPED Attachment 2 to COLLEAGUE Important Product Information Letter Dated 12 13 05
7. d an obstruction during IV administration set loading e Ensure that when loading the IV administration set the tubing is loaded along the entire length of the tubing channel to avoid a misload or incomplete load situation e Never insert tools or other objects into the tubing channel when attempting to load or unload the administration set e Never use the Manual Tube Release to load or unload the administration set during normal operation If you suspect the accuracy of your pump may be affected perform the Annual Operational Checkout process which includes an accuracy test as described in the Service Manual if the pump fails the accuracy test remove the pump from service and have the pump inspected by authorized service personnel following the instructions outlined in the COLLEAGUE Volumetric Infusion Pump Service Manual Baxter is in the process of verifying changes to the pumping mechanism to better secure these components to reduce the potential for component movement and resulting underinfusion Baxter will notify you when these changes are available COLLEAGUE and Baxter are registered trademarks of Baxter ternational inc 2005 072 MD Caxter Non Detection of Upstream Occlusion As previously communicated in the attached March 17 2005 Urgent Device Correction Buretrol letter there is a potential for non detection of upstream occlusion when Buretrol tubing sets are used with the Colleague Volumetric Infusion pump In ad
8. d drying on the mechanism Avoidance of the Panel Lockout Button During storage or patient transport do not wrap the pump s power cord around the pump tightly enough to accidentally press the PANEL LOCKOUT button on the back Baxter recommends securing the power cord with the strap provided with the pump instead of wrapping the power cord around the pump Verification of Infusion Site and Route Clinicians are advised to verify the proper route of delivery and that the infusion site is patent When using this pump periodic patient monitoring must be performed to ensure that the infusion is proceeding as expected The pump is capable of developing positive fluid pressures to overcome widely varying resistances to flow such as resistance imposed by small gauge catheters filters or intra arterial infusions Although the pump is designed to stop fiuid flow when an alarm occurs it is neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions Piggyback Infusion Feature When using the piggyback infusion feature ensure e The medication solution in the secondary source container is compatible with the medication solution in the primary source container e The secondary administration set is connected to the appropriate injection site on the Continu Flo administration set e The interruption of the primary infusion is clinically appropriate for the duration of the piggyback infusion Attachment 2
9. dition to the condition described above the following conditions should be avoided as they may result in the pump not detecting an upstream occlusion e Use of a source container which has had all air removed e Incomplete insertion of the spike into the source container e Improper venting of a rigid glass bottle or semi rigid plastic container including Buretrols If using rigid non vented containers refer to the appropriate administration set instructions to determine the correct venting procedure e Unopened air vent above the burette chamber during infusion To help ensure upstream occlusions are detected by the pump when using a Buretrol set do not invert the set and squeeze fluid back into the primary container Doing this may wet out the vent filter and obstruct airflow Baxter will notify you when the new release of the COLLEAGUE Volumetric Infusion Pump Operators Manual is available In the meantime please immediately disseminate the attachments to all users If you have any questions about this or any other issues regarding COLLEAGUE pumps please contact Baxter Medication Delivery Services at 1 800 THE PUMP 1 800 843 7867 Please complete the attached reply form confirming your receipt and understanding of this letter and fax it back to Baxter at the number provided on the form Returning the form promptly will prevent you from receiving a repeat notice If you provide the COLLEAGUE Volumetric Infusion Pump to other ser
10. m promptly will prevent you from receiving a repeat notice If you provide the affected BURETROL Sets to other services or facilities please forward this communication as appropriate Since these products are no longer recommended for COLLEAGUE pump use you may wish to return the products for credit and order an altemative by calling Baxter Healthcare Center for Service at 1 888 229 0001 We apologize for any inconvenience this will cause you and your staff If you have questions regarding this communication please call the Center for One Baxter at 1 800 422 9837 The Food and Drug Administration has been notified of this action Sincerely Signature Dirk E Stevens Vice President Quality Medication Delivery Division Baxter Healthcare Corporation Buretrol and Baxter are Trademarks of Baxter International Inc 2005 023 MD
11. s can be recharged Pump batteries should be evaluated yearly by Baxter trained qualified personnel according to the procedures in the Service Manual and whenever it is suspected that any of the conditions listed above may have occurred Baxter trained qualified personnel can view the pump s Battery and Pump History screen using the instructions provided in the Service Manual Attachment 1 to COLLEAGUE Important Product information Letter Dated 12 13 05 Product Information Infusion Management Guide It is imperative that institutions have a contingency plan to mitigate any disruptions of infusions of life sustaining drugs The interruption or delay of life sustaining therapy may result in potential injury or death You should consider not using these pumps in situations where a replacement pump is not available or where an interruption in therapy may be life threatening Generation of Air Detected Alarm Due to IV Administration Set Tugging Pulling or tugging on the administration set tubing between the pump channel and the patient may cause a false Air Detected alarm which will cause the pump to stop infusing In order to reduce the potential for this situation to occur 1 First select an appropriate length administration set 2 Before loading the set into the pump position the keyed slide clamp at an appropriate location along the tube segment to ensure that there is adequate length of tubing between the patient
12. uation to occur first select an appropriate length administration set Before loading the set into the pump position the keyed slide clamp at an appropriate location along the administration set to ensure that there is adequate length of tubing between the patient and the pump to reduce tugging on the set during activities such as moving the patient from one bed to another or transportation of the patient from one facility location to another Gearbox Wear Baxter has identified that worn gearbox components can result in Failure Codes 812 02 and 812 05 which will result in an audible and visual alarm and the interruption of therapy As this is associated with age and wear on the pump older pumps are more prone to exhibit these failures As stated in the Operator and Service Manuals if you experience these failure codes immediately remove the pump from service and have the pump evaluated by Baxter trained service personnel Baxter is in the process of developing actions to address this issue and will notify you once they are finalized Underinfusion Baxter has received reports of underinfusion on the COLLEAGUE Volumetric Infusion Pump Our investigation has shown that in the presence of an obstruction during IV Administration set loading certain pump head components can be moved out of alignment resulting in underinfusion The amount of underinfusion is typically 5 to 9 but may be up to 19 below the programmed infusion rate To avoi
13. vices or facilities please forward this information as it is imperative that all end users are notified and confirm receipt of this notification Additionally if your pump is serviced by a third party please forward this information to the service provider The Food and Drug Administration has been notified of this communication Sincerely Signature Robert Smith Senior Director Quality Medication Delivery Baxter Healthcare Corporation Attachments Attachment 1 Battery Usage Guide Attachment 2 Infusion Management Guide Attachment 3 March 17 2005 Urgent Device Correction Buretro Letter CC Director of Biomedical Engineering COLLEAGUE and Baxter are registered trademarks of Baxter International Inc 2005 072 MD COLLEAGUE VOLUMETRIC INFUSION PUMP PRODUCT CODES 2M8151 amp 2M8151R COLLEAGUE 3 VOLUMETRIC INFUSION PUMP PRODUCT CODES 2M8153 amp 2M8153R COLLEAGUE CX VOLUMETRIC INFUSION PUMP PRODUCT CODES 2M8161 amp 2M8161R COLLEAGUE 3 CX VOLUMETRIC INFUSION PUMP PRODUCT CODES 2M8163 amp 2M8163R Customer Reply Form Urgent Device Correction letter dated December 13 2005 Please complete and return this form to the FAX number listed below as confirmation that you have received this notification A fax cover sheet is not required 1 847 270 5457 Facility Name and Address t Reply Confirmation Completed By Fiease print name 5 Title Fleas e pnnt Telephone Number
14. y Depleted Alarm e A pump stored with its power cord unplugged especially with low or depleted batteries e More than one deep battery discharge as indicated on the pump s Battery and Pump History screen e Batteries discharged recharged more than 68 times as indicated on the pump s Battery and Pump History screen e Failure of the Battery Discharge Test included in the Colleague Pump Global Service Manual Continued pump operation using batteries that have been subjected to any of the above conditions may result in cessation of therapy and or device failure and loss of configuration memory Always do the following to properly maintain the pump batteries Keep pumps plugged into an AC power outlet at all times except in the event of AC power loss or short term portable operation Always store pumps plugged into AC power to maintain the battery charge whenever possible When a Battery Depleted Alarm occurs immediately plug the pump into a source of AC power Do not use the pump on battery power again until the batteries have been fully recharged Charge the battery for a minimum of 12 uninterrupted hours after a Battery Depleted Alarm occurs Never store the pump unplugged and powered on The batteries may discharge completely permanently damaging them Notify Central Supply or other appropriate departments as soon as a pump is removed from patient use so that it can be cleaned and the batterie
Download Pdf Manuals
Related Search