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السبت - جمادى الآخرة 8, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-26-10-25-1110
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اسم الجهاز الطبي
BD Alaris System Pump (8100) & Bezel Spare Parts
الأجهزة المتأثرة
Product Name: Product Code (REF), UDI-DI, Serial/Lot Number BD Alaris™ Pump Module Model 8100: Product Code (REF) 8100, (UDI-DI): Please refer to the attachment, All serial numbers KIT, BEZEL ASSY 8100BD: Product Code (REF) 49000437, (UDI-DI): 10885403471018, Serial/Lot Number N/A KIT ASSY ONE PIECE BEZEL 8100: Product Code (REF) 49000270, (UDI-DI):10885403247743, Serial/Lot Number N/A
الممثل المعتمد
Becton Dickinson BV Saudi Limited Company
سبب المشكلة
Dropping the Alaris Pump Module may cause damage to internal components that may not be apparent or readily visible. More specifically, drops or severe jarring may damage the Alaris Pump module bezel assembly, which provides the mechanical foundation for critical pumping components. This damage can cause under-infusion, over-infusion, unregulated flow, or failure of the Alaris™ Pump module to calibrate.
الإجراء التصحيحي
1. Customers should NOT USE a device that has been dropped or severely jarred. Devices that have been dropped or severely jarred should be segregated and sent to biomedical engineering for inspection, as directed in the BD Alaris™ System with Guardrails™ Suite MX User Manual. 2. Prior to use, inspect the Alaris™ Pump Module for visual damage. If the device has physical damage, remove from service and send to biomedical engineering for further inspection and testing, as directed in the BD Alaris™ Infusion System User Manual, refer to the attachment. 3. Perform the testing as specified in the Level of Testing Guidelines in your Technical Service Manual for a dropped device, including rate accuracy verification testing. If any test fails, perform the applicable steps in the troubleshooting section of your Technical Service Manual, which may include replacement of the pumping mechanism. See Technical Service Manual Section. 4. Continue to perform annual preventive maintenance, including rate accuracy verification (as discussed in the previous action item), on all of your Alaris™ Pump modules, as specified in the Alaris System Maintenance Guide. Preventive maintenance is important in ensuring regular testing of any potentially dropped or damaged device that was not immediately removed from use. 5. BD is providing a Tip Sheet (Appendix A) in the attachment. The Tip Sheet is intended to remind all personnel who handle the Alaris™ Pump Modules that dropped/damaged units should be removed from service and inspected. 6. BD will be adding reinforcements to applicable labeling to reiterate that if devices are dropped or severely jarred, they should be removed from service and inspected. These warnings currently exist in your Alaris™ System with Guardrails™ Suite MX User Manual. Manufacturer's Action: Instructions and Correction.
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