التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

1. You may continue to perform therapy using the Prismaflex sets listed in the attachment. Please monitor the
deaeration chamber during therapy to ensure it remains in an upright position within the holder.

If attempting to secure the deaeration chamber in an upright position, please consider the following:
-	Ensure there are no kinks in the tubing and that the deaeration chamber remains visible.
-	If the Prismaflex Control Unit issues an “Air in Blood” alarm, check if air is present. If there is no air present, check if the deaeration chamber is dislodged from the holder and ensure there are no clots present.
1. If no dislodgement, please follow the operator’s manual instructions for “Air in Blood” alarm.
2. In case of dislodgement with clotting, follow the associated instructions within the Prismaflex Control Unit operator’s manual to stop the therapy and replace the set.
3. Only in case of dislodgement without clotting or any other alarms, if the chamber is secured in an upright position, follow the associated instructions within the Prismaflex Control Unit operator’s manual to proceed with treatment.

Manufacturer's action: Instructions.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-13-01-26-1209