التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

1) Read the attachment.
2) If further assistance is needed regarding the Backup Battery Alarm after following Instructions for Use, contact your Abbott Representative for troubleshooting steps to determine if a battery or system controller replacement is required for resolution.
3) The HeartMate II® and HeartMate 3™ Left Ventricular Assist System (LVAS) Clinical Instructions for Use (page 7-20 for HeartMate II®, page 7-23 for HeartMate 3™) outlines that if the Backup Battery Fault Alarm is active, patients should first ensure that they remain on external power sources (e.g. 14V batteries or AC power via the Mobile Power Unit) until the issue is resolved. During this time, the pump is operating as intended and providing flow. To resolve the issue:
• Patients must call their hospital contact immediately for diagnosis and instructions.
• If a System Controller exchange is needed, remind the patient that a caregiver must be present during the exchange and that all labeling instructions on System Controller exchange must be followed.
• If a backup battery replacement is needed, advise the patient to visit your clinic and have a clinician replace the System Controller 11 Volt Lithium-Ion backup battery (see page 2-41 for HeartMate II® and page 2-39 for HeartMate 3™).

A change in the System Controller Backup Battery connection interface is being developed and qualified by Abbott to address this issue, which will be implemented soon.

Manufacturer's Action: Instructions and Correction.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-15-10-25-1096