تسجيل الدخول
تسجيل جديد
الجمعة - ذو القعدة 11, 1446
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-08-07-24-501
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
HeartMate 3 LVAS
الأجهزة المتأثرة
HeartMate 3™ LVAS Implant Kit (Model: 106524INT) HeartMate 3™ System Controller (Model: 106531INT) HeartMate 3TM System Controller Low Flow 2.0 (Model: 106531LF2)
الممثل المعتمد
ALJEEL MEDICAL COMPANY
سبب المشكلة
A potential for the controllers to have a lifted User Interface (UI) membrane that when present, is observed along the edge of the controller housing, near the Display Button.
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.
المرفقات
عودة للقائمة