التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

• Carefully inspect the controller at the edge near the Display Button to confirm that the UI membrane is not lifted
(refer to provided visual examples in the attachment) prior to using the controller or providing the controller to your patient. Do not provide controllers with lifted UI membrane to your patients and report controllers with lifted UI membrane by
contacting your local Abbott Representative. Note that controllers that do not present a lifting UI membrane will
not lift over time.
• Provide enclosed Patient Letter to patients who have received a HeartMate 3™ System Controller (Model:
106531INT, 106531LF2) starting March 2024, to explain this issue and reinforce to follow these instructions in
the Patient Handbook (PHB):
• Reinforce requirement to patient to perform the daily Self-Test to verify the display works appropriately as listed
in “Performing a System Controller Self-Test” of the IFU, and pages 2-26 – 2-27 of the PHB. These sections
can be downloaded from the Abbott Manuals website eLabeling | Abbott (eifu.abbott) which can be accessed at
https://manuals.eifu.abbott/en/index.html .
• Reinforce “General Warning” and “Warnings and Cautions” within the IFU and the PHB to protect the controller
from exposure to fluids and keep it dry at all times. In addition, patients who are permitted to shower by a
doctor, must use the Shower Bag for every shower. The Shower Bag protects the external system components
from water and moisture.

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