تسجيل الدخول
تسجيل جديد
الثلاثاء - ربيع الآخر 22, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-12-10-25-1089
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
BD Alaris Syringe Pumps
الأجهزة المتأثرة
Please refer to the attachment for details
الممثل المعتمد
Becton Dickinson BV Saudi Limited Company
سبب المشكلة
A potential manufacturing defect affecting certain BD Alaris™ Syringe Pumps related to keypad functionality. It has been observed that specific lots of the keypad components may exhibit unintended behaviour impacting the “On/Off”, “Hold” and “Run” keys.
الإجراء التصحيحي
Organize for the affected Alaris™ Syringe pumps serial numbers to be made available to BD, your Biomedical Engineering team or to your Service Organisation as applicable for keypad replacements. Continue to use the Alaris™ Infusion pumps with their existing labeling and Directions for Use. In case you observe the pump presenting with the described issue, immediately remove it from service for inspection by Qualified Service Personnel. Use an alternative syringe pump in the meantime, refer to the attachment for more information. Manufacturer's Action: Instructions and Correction.
المرفقات
عودة للقائمة
