Subject: Update to the Important Device Field Information Letter
Contents
1. LifeCare PCA LifeCare PCA with MedNet List Number 20709 Undetected Distal Occlusions Caused by a Worn Half Nut If you have further distributed these devices please notify your accounts who may have received these devices from you and ask them to complete the attached reply form and to return it For further inquiries please contact Hospira using the information provided below Hospira Contact Contact Information Areas of Support Canadian Service 1 866 488 6088 Option 5 2 To report adverse events or product Center CanadaPumpSupport hospira com complaints 1 866 488 6088 Option 4 Hospira Clinical S rt OS pra M IPIGA URPO mail ClinSupport hospira com For further clinical inquiries Hospira is committed to providing our customers with the highest level of service and product quality We appreciate your cooperation and we regret any inconvenience this action may cause Sincerely Zm Rania Al Ammar Regional Director Commercial Quality2. com If your facility has not yet taken the above steps Hospira recommends taking them immediately Additionally Hospira committed to e Establish a useful life for the half nut e Add a requirement for an annual PVT Occlusion Test to the Technical Service Manual TSM e Update the System Operating Manual SOM regarding proper vial resetting technique As such Hospira is now informing you that e Hospira determined that the useful life of the half nut is sixty 60 months e the updated TSM incorporating the annual PVT Occlusion Test requirement is now available e the updated SOM incorporating the proper vial resetting technique into section Loading a Vial 4 4 and 4 5 is now available Hospira Healthcare Corporation 1111 Dr Frederick Philips Blvd Suite 600 Saint Laurent Qu bec Canada H4M 2X6 Page 1 of 4 Hospira recommends the following Hosp j ra Instructions and recommended action List no 20709 LifeCare PCA Instructions and recommended action List no 01950 PCA Plus 2 List no 12384 PCA Plus 3 1 Some LifeCare PCA LifeCare PCA with Hospira MedNet devices may be older than or approaching the useful life of the half nut 60 months As a result Hospira will provide customers with replacement mechanisms containing a new half nut Customers will have the option to replace the mechanisms themselves or ask Hospira for technical assistance For customers electing to perform the replacement Hospira wi
3. A Technical Service Manual TSM and the updated LifeCare PCA System Operating Manual SOM and provided made available a copy to users in my facility o __YES o ___NO please explain Hospira Healthcare Corporation 1111 Dr Frederick Philips Blvd Suite 600 Saint Laurent Qu bec Canada H4M 2X6 Page 4 of 4 5 2 PREVENTIVE MAINTENANCE 5 2 PREVENTIVE MAINTENANCE Hospira requires that preventive maintenance be performed at least once every 12 months Replace components as required by visual inspection and test results Complete the Preventive Maintenance Checklist in Section 5 2 1 The sealed lead acid battery must be replaced at least once every 24 months The mechanism assembly must be replaced at least once every 60 months see Figure 7 8 The coin cell battery must be replaced at least once every 120 months Perform the preventive maintenance inspections and tests according to the following steps 1 Section 5 2 1 Preventive Maintenance Checklist 2 Section 5 2 2 AC Power Cord Inspection and Test 3 Section 5 2 3 Front Enclosure Rear Enclosure Cradle Assembly and Security Door Inspection and Test 4 Section 5 2 4 Rubber Foot Pad Inspection 5 Section 5 2 5 Pole Clamp Assembly Inspection and Test 6 Section 5 2 6 Keypad Displays LED LCD and Indicators Inspection 7 Section 5 2 7 Patient Pendant Inspection 8 Section 5 2 8 Barcode Reader Window Inspection Test and Cleaning Technical Servi
4. Hospira Subject Update to the Important Device Field Information Letter Issued on March 7 2013 for LifeCare PCA infusers Undetected Distal Occlusions Caused by a Worn Half Nut August 29 2014 Dear Healthcare Professional Hospira Healthcare Corporation Hospira issued the attached Important Device Information on March 7 2013 due to reports of PCA pumps not detecting distal occlusions This issue is caused by normal wear and tear on the half nut the component nut that travels up and down the lead screw which prevents it from properly detecting the pressure build up associated with a distal occlusion Notification Impacted Product Impacted product list number PCA Plus 2 List no 01950 XX Update to letter issued on PCA Plus 3 List no 12384 XX March 7 2013 LifeCare PCA LifeCare PCA with Hospira MedNet Hstno 20709 XX In the March 7 2013 letter Hospira recommended that facilities immediately inspect their PCA devices to determine if the half nut was worn and unable to effectively detect a distal occlusion by performing the following steps e Perform the Performance Verification Test PVT Occlusion Test as defined in the PCA Technical Service Manual TSM e f your device does not pass the PVT Occlusion Test remove it from clinical service and contact the Hospira Canadian Service Center to report the issue at 1 866 488 6088 Option 5 2 or by email at CanadaPumpSupport hospira
5. ate your cooperation and we regret any inconvenience this action may cause Hospira Canadian Service Center Sincerely Z7 Rania Al Ammar Regional Director Commercial Quality Hospira Healthcare Corporation 1111 Dr Frederick Philips Blvd Suite 600 Saint Laurent Qu bec Canada H4M 2X6 Page 3 of 4 Reply Form RESPONSE REQUIRED LifeCare PCA Infusers Update to Letter Important Device Field Information Issued on March 7 2013 Hospira Fax the completed form to 1 877 906 0208 or email to canadarecall hospira com General Required Customer Information Customer Number ship to Business Name Adaress City Province Postal Code Contact Name Contact e mail Phone Number Fax Number Signature Date e have received the letter and have notified users in my facility o YES o NO please state reason o Devices transferred no longer owned please indicate new owner contact information Business Name Address City State ZIP Contact Name Contact Phone E mail Address o _ Other please explain e Have you distributed the product further to the retail level o _ YES if yes have you notified your retail customers _ YES ___NO please explain o NO e We intend to replace the mechanisms in our LifeCare PCA ONLY List Number 20709 utilizing our own resources o __YES o ___NO please explain e have downloaded BOTH the updated LifeCare PC
6. ce Manual 5 3 LifeCare PCA with Hospira MedNet SECTION 5 MAINTENANCE AND SERVICE TESTS 5 2 1 PREVENTIVE MAINTENANCE CHECKLIST The Preventive Maintenance process must be performed at least once every 12 months to ensure proper performance of the PCA infuser In addition inspect the infusion system after repair or during cleaning Replace any damaged or defective external parts as required Perform the Performance Verification tests as described in Section 5 3 and replace components as described in Section 7 Hospira LifeCare PCA with MedNet Infusion System Preventive Maintenance Checklist Circle PASS or FAIL in the respective box after each inspection or test is performed Enter the device model and serial number in the space provided Sign and date this checklist in the space provided Tem Inspection Test AC Power Cord Inspection and Test PASS FAIL PASS FAIL Front Enclosure Rear Enclosure Cradle Assembly and Security Door Inspection and Test PASS FAIL PASS FAIL Rubber Foot Pad Inspection PASS FAIL Pole Clamp Assembly Inspection and Test PASS FAIL Keypad Displays LED LCD and Indicators Inspection PASS FAIL Patient Pendant Inspection PASS FAIL Barcode Reader Window Inspection Test and Cleaning PASS FAIL Self Test Biomed Mode Tests Delivery Accuracy Test Occlusion Test Electrical Safety Te
7. ll provide instructions for how to document and return the replaced mechanisms Customers will be required to provide Hospira with the serial numbers of the devices serial numbers of the mechanisms removed serial numbers of the mechanisms installed and confirmation that the devices passed the PVT Customers will also be required to return this information and the removed mechanisms Hospira anticipates beginning this activity in Q4 2014 2 Hospira has added a requirement to Section 5 2 of the TSM to replace the mechanism assembly at least once every sixty 60 months Hospira has also incorporated into Section 5 2 of the TSM a requirement to perform a performance verification test PVT at least once every 12 months The specific PVT Occlusion Test can be found in section 5 3 6 of the TSM 3 Customers can download the updated TSM and SOM from the Hospira website at www hospira ca english newsandmedia aspx Hospira recommends that you provide the updated TSM and SOM to users in your facility as soon as possible 4 Once you have downloaded both the updated TSM and SOM please complete the attached reply form and return it to the fax number or e mail address indicated on the form even if you do not have the affected product If you have further distributed these devices to the retail level notify your accounts who may have received the product and ask them to complete and return the attached Reply Form to Hospira As a result of the May 2013 H
8. ospira global device strategy press release announcing the retirement of the legacy PCA List Numbers 1950 and 12384 the above actions will only apply to the LifeCare PCA List Number 20709 Users of legacy PCA should ensure to perform the PVT Occlusion Test as per the TSM instructions at least every 12 months and continue to follow the proper vial resetting technique outlined below a Grasp the cradle release mechanism and squeeze completely b Continue to squeeze the release mechanism during movement of the cradle c A grinding sound should not be audible and the release mechanism should slide freely to prevent damage The instructions included in this letter contain all of the information that would have been added to the TSM and SOM for the legacy PCA Hospira Healthcare Corporation 1111 Dr Frederick Philips Blvd Suite 600 Saint Laurent Qu bec Canada H4M 2X6 Page 2 of 4 Health Canada has been notified of this action H OSs p j re d For further inquiries please contact Hospira using the information provided below Hospira Contact Contact Information Areas of Support To report adverse events or 1 866 488 6088 Option 5 2 z CanadaPumpSupport hospira com product complaints on the pump F i 1 866 488 6088 Option 4 3 aa Hospira Clinical Support mail ClinSupport hospira com For further clinical inquiries Hospira is committed to providing our customers with the highest level of service and product quality We appreci
9. st Connectivity Check Signature Battery Replaced YES NO Model Date LifeCare PCA with Hospira MedNet Serial Number Technical Service Manual IMPORTANT DEVICE INFORMATION LifeCare PCA Plus 2 List Number 01950 LifeCare PCA 3 List Number 12384 LifeCare PCA LifeCare PCA with MedNet List Number 20709 March 7 2013 Undetected Distal Occlusions Caused by a Worn Half Nut Dear Healthcare Professional Hospira Inc Hospira is issuing this letter because we have received reports of PCA pumps not detecting distal occlusions This letter details the potential risk and recommended steps to take if you encounter this issue Affected Units Issue Risk to Health Required Action Hospira Actions LifeCare PCA Plus 2 List Number 01950 LifeCare PCA 3 List Number 12384 LifeCare PCA LifeCare PCA with MedNet List Number 20709 This issue is caused by normal wear and tear on the Half Nut the component nut that travels up and down the lead screw which prevents it from properly detecting the pressure build up associated with a distal occlusion Undetected distal occlusions could result in delay or interruption of therapy Hospira recommends that facilities immediately inspect their PCA devices to determine if the half nut is worn and unable to effectively detect a distal occlusion by performing the following steps Perform the Performance Verification Tes
10. t PVT Occlusion Test as defined in the PCA Technical Service Manual TSM e lf the device does not pass this test remove it from clinical service and contact the Hospira Canadian Service Center at 1 866 488 6088 Option 5 2 to report the issue e Perform the appropriate troubleshooting and repair activities defined by your facility which may include returning the device to Hospira for further diagnosis and servicing This issue is caused by normal wear and tear and is not the result of a defect thus no corrective actions will be required to address this issue Hospira is in the process of establishing a useful life for the half nut to determine when it will require replacement Additionally a requirement for an annual PVT Occlusion Test to verify the proper operation of the half nut is being developed Both of these changes will be integrated into the Technical Service Manual in late 2013 To reduce the excessive wear on the half nut resulting from incorrectly using the vial information will be added to the System Operating Manual SOM Health Canada has been notified of this action Please complete the attached reply form and return it to the fax number or e mail address on the form even if you do not currently have the impacted devices Dr Frederi aurent Qu bec C 6 tage Suite 600 H4M 2X6 IMPORTANT DEVICE INFORMATION LifeCare PCA Plus 2 List Number 01950 LifeCare PCA 3 List Number 12384
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