URGENT FIELD SAFETY NOTICE Dialog+ SW 9.xx Two
Contents
1. Article Code 7102013 710201G 710207E 710201C 710201T 710207F 710201E 710201U 710207P 7102011 710201XV 710207T 7102018 710201D 710207X 710201CV 7102072 710207EV only use your count y specific article code Please fill in this form and return it by fax immediately to the fax number Please fill in your fax number We hereby confirm that we are aware of the Field Safety Notice from date concerning the Dialog SW 9 xx with two pumps incl HDF online The Field Safety Notice was communicated within our organization We also confirm that we checked our machines with the following result O Test passed in all machines O Test failed in machines Please fill in the number of machines in which the test failed Name Telephone Number Date and Signature Stamp November 13 2014 Assembly and Detailed Testing Instruction e Dialog SW 9 xx e Level Regulation Option Tubing Connection between Diaphragm Pump and Valve Block Level Regulation 1 Related Machines Dialog machines with software 9 xx and a level regulation option 2 Assembly and Detailed Testing Instruction It is technically possible to connect the two tubes between the diaphragm pump and the valve block level regulation wrongly during a service activity when the diaphragm pump or when the valve block level regulation is replaced i e the tubing can be inverted B at the pump or at the valve block This inverted connection B will cause a malfunction of the le2. URGENT FIELD SAFETY NOTICE Dialog SW 9 xx Two Pump Machines incl HDF online in which level regulation spare parts were exchanged R 2014 002 From B Braun National Organization Distributor TO Customer Name Affected Article Codes 7102013 7102072 710201C 710207E 710201E 710207F 7102011 710207P 7102018 710207T 710201CV 710207X 710201G 710207EV 710201T 710201U 710201XV 710201D only use your country specific article code in which the following spare parts were exchanged 34560823 Diaphragm Pump 34560831 Valve Block Level Regulation DP 3456083A Valve Block Level Regulation DP only use your country specific article code Dear Sir Madam In the context of our continuous post market surveillance it became known to us that following the exchange of the valve block level regulation and or the diaphragm pump by a service technician an interchanged connection of the tubing between these components cannot be completely excluded if the functionality is not tested as requested in the service manual This results in an incorrect function of the manual level regulation Only in a Single Needle Cross Over therapy manually raising the level in the arterial chamber leads to a lowering of the level If this is not realized by the user and the function key is continuously pressed this can lead to an air infusion through the arterial line Ex factory this failure of the Dialog dialysis machines is excluded P
3. odule_EN doc pdf Rev 1 00 00 2014 November SHARING EXPERTIS
4. otentially affected are only Dialog dialysis machines in which the above mentioned components were exchanged during a technical service Only one single case was reported in which the tubing was wrongly connected by the customer s service technician The functional test requested in the service manual was not performed completely in this case There was neither an air infusion nor any other consequences for patient user or third party To completely exclude a wrong connection of the tubing in the future a detailed service instruction will be enclosed to the spare parts valve block level regulation and diaphragm pump Actions to be taken by you To check whether your Dialog SW 9 xx Two Pump Machines incl HDF online do not have the described failure we ask you NOT to perform any SN CO therapy before you have tested the correct function of the manual level regulation You can easily check for correct function during preparation of the next upcoming treatment This is possible in any treatment mode Please act according to the following steps 1 Prepare the Dialog in the required therapy mode and fill the bloodlines The venous chamber should be half full 2 Lower the level in the venous chamber by pressing the function key 3 Observe the level in the venous chamber a if the level lowers the Dialog is working correctly b if the level increases the Dialog working faulty separate and label the Dialog and contact your service
5. technician Prepare the en i araar P PY Charba PA Chorba Lewel Riegullet c level does nae N Sonn 7 lower OK SVV 9 xx in ER required therapy modc lower ithe level in the and fill the bloodlines venous chamber AI l J 5 level separate contact 1 gt n increases Dialog servicc Jl Please make sure that all users of the above mentioned products in your organization and other concerned persons are informed about this Field Safety Notice If you have forwarded the products to a third party please forward a copy of the Field Safety Notice to them or inform the contact person mentioned below Please retain this Field Safety Notice until you have completed all the above measures Y ou will be informed as soon as the modified product is available The National Competent Authority has been notified of the Field Safety Corrective Action We are available to personally answer any questions you may have regarding this issue and the proposed actions Please contact local contact We kindly ask you to confirm the receipt of this information by completing the attached form and returning it by fax to the indicated fax number We apologize for the inconvenience caused Sincerely Please fill in your signature job title etc here Confirmation of Receipt of Field Safety Notice Dialog SW 9 xx Two Pump Machines incl HDF online in which level regulation spare parts were exchanged R 2014 002
6. vel regulation system during the required functional check Only in a single needle cross over treatment the intended increasing of the level of the arterial cross over chamber can actually lead to an air infusion into the patient through the arterial patient connection Fig Correct connection A Fig Incorrect connection B 3 Service Activities The correct connection of the tubing A shall be ensured after assembly by a visual check as well as a functional check by increasing and decreasing the levels inside the chambers using the Up and Down icons in a simulated treatment The machine shall be released for patient use only if the level regulation works correctly i e the level decreases when the Down icon is activated and the level increases when the Up icon is activated This check shall be performed for all chambers of the connected tubing system to ensure the correct function of the option Air infusion possible via the arterial line in Single Needle Cross Over mode only gt Prepare the machine for a simulated treatment gt Activate the Up and Down icons for each chamber gt Confirm that the levels in the respective chambers actually increase and decrease WARNING With best regards For more information please contact your local B Braun Medical support B Braun Avitum AG 34209 Melsungen Germany Telephone 49 0 5661 71 5015 E Mail techsupport_ba bbraun com B BRAUN FSI_2014 04 DialogP_SW 9xx_Level Regulation M
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