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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 030 05 18 001
Date submitted: 6/9/2018
Manufacturer:HeartWare Inc.
Device Type:Medtronic HeartWare™ HVAD™ System
Description:Circulatory Assist Units, Cardiac, Ventricular
Medical Device Identifier:Models: 1400, 1401, 1403, 1407, 1420, 1435, 1440, 1425, 1430, 1650
Reason of Field Safety Corrective Action:HeartWare, now a part of Medtronic, is providing this letter to inform you of the potential for a transient interruption of the electrical connection between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the HVAD Controller that may result in unintended power switching to the secondary power source and/or unexpected audible tones (“beeping”). This interruption, which occurs while the power source remains physically connected, is due to oxidation of connecting surfaces between a power source connector and the controller’s power source socket, and typically lasts 1-2 seconds.
Unexpected beeping occurs when the interruption automatically resolves and may cause confusion to the patient or caregiver, as the controller may display sufficient battery capacity or AC/DC connectivity at the time of the audible tone. A Critical Battery Alarm may also be momentarily displayed due to this phenomenon.
Remedy Action:Kindly check the "Patient Management Recommendations" section in the attached FSN.

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NCMDR update action:

We are writing to inform you that a lubricant solution that can be applied to HeartWare™ HVAD™ System power source connectors, as a method for mitigating unexpected transient power switching due to the effects of oxidation, is now available.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:7DA0BD9E8C304, 7DA0BD9E8C304
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf