BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 11302189 · Received February 9, 2021

    Report

    Report Number
    2916596-2021-00654
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    March 13, 2020
    Report Date
    February 9, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE MPU WAS "RATTLING" WHILE MOVING AND SHAKING THE DEVICE WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED MPU-37442 WAS UNREMARKABLE. THE MPU WAS DISASSEMBLED AND THERE WAS A SCREW FLOATING INSIDE. FURTHER EVALUATION REVEALED ALL THE REQUIRED SCREWS FOR THE MPU WERE PROPERLY SECURED. THE EXTRA SCREW WAS REMOVED AND THE MPU WAS CONNECTED TO THE LABORATORY TEST EQUIPMENT. THE MPU OPERATED AS INTENDED. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE PASSED ALL STEPS. IN ORDER TO PREVENT SIMILAR ISSUES OF LOOSE SCREWS INSIDE THE MPU, THE QAP WILL BE UPDATED TO CLARIFY THE INSPECTION STEPS AND THE TEAM WILL BE RETRAINED. HEARTMATE 3 PATIENT HANDBOOK AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU), CAUTION THE USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE MPU WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN MOBILE POWER UNIT (MPU) WAS ORDERED FOR A NEWLY IMPLANTED PATIENT, UPON ARRIVAL OF THE MPU, THERE WAS A RATTLING WHEN MOVING THE MPU. NO LOOSE SCREWS WERE NOTED. THE MPU WAS EXCHANGED AS AN OUT OF BOX FAILURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201315 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 100159807 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR