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السبت - جمادى الآخرة 8, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-15-10-25-1095
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
CentriMag Blood Pump
الأجهزة المتأثرة
CentriMagTM Blood Pump (201-90010) Blood Pump with CentriMag™ Acute Circulatory Support System for ECMO (CMAEK01)
الممثل المعتمد
ALJEEL MEDICAL COMPANY
سبب المشكلة
The bottom housing rim of the pump did not meet specifications for flatness and thickness. This flatness and thickness issue may prevent proper insertion of the pump housing into the CentriMag Motor, potentially leading to misalignment.
الإجراء التصحيحي
1) Read the attachment thoroughly. 2) Ensure the CentriMag Blood Pump is securely locked into the motor, following the IFU. If you are unable to fully rotate and lock a blood pump into a motor, exchange the pump for a new one, and return the original pump to Abbott. 3) Continue to follow Abbott IFU for the CentriMag Motor for setting up the system as described in the Section “Pump Setup” in Appendix A in the attachment. Instructions for Use are available for the CentriMag™ Blood Pump and Motor on the Abbott website (https://manuals.eifu.abbott/en/index.html). Manufacturer's Action: Instructions and Removal.
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