BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, EU

    MDR report key: 24333674 · Received February 13, 2026

    Report

    Report Number
    2916596-2026-00648
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 23, 2026
    Report Date
    April 22, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010890
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFO WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE REPORTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE MOBILE POWER UNIT¿S (MPU¿S) PINS BEING DAMAGED WAS CONFIRMED, AS THE RETURNED MPU (SERIAL NUMBER (B)(6)) WAS OBSERVED TO BE MISSING TWO PINS FROM ITS PATIENT CABLE, ONE FROM ITS WHITE LEMO CONNECTOR AND ONE FROM ITS BLACK LEMO CONNECTOR. THE MPU WAS FUNCTIONALLY TESTED AT THE EUROPEAN DISTRIBUTION CENTER AND WAS FOUND TO PERFORM AS INTENDED DESPITE THE MISSING PINS. THE MPU¿S PATIENT CABLE WAS REPLACED WITH A NEW ASSEMBLY, THEN THE SERVICED AND REPAIRED MPU WAS RETURNED TO THE RENTAL POOL AFTER PASSING ALL TESTS PER PROCEDURE. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOR THE MOBILE POWER UNIT, SERIAL NUMBER (B)(6), SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK (SECTION 10 ¿SAFETY CHECKLISTS¿) AND THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (SECTION F ¿SAFETY CHECKLISTS¿) INSTRUCTS USERS TO REGULARLY INSPECT THEIR EQUIPMENT, INCLUDING THEIR MPU, AND TO AVOID USING EQUIPMENT THAT APPEARS DAMAGED. USERS ARE ENCOURAGED TO REPLACE ANY EQUIPMENT THAT APPEARS DAMAGED. THE HEARTMATE 3 PATIENT HANDBOOK (SECTION TITLED "EMERGENCY CONTACT LIST") CAUTIONS 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 CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE PATIENT WANTED TO CONNECT TO THE MOBILE POWER UNIT (MPU), IT WAS NOT POSSIBLE. THERE WAS A POWER CABLE DISCONNECT ALARM FOR BOTH SYSTEM CONTROLLERS. THE SYSTEM CONTROLLERS WERE INSPECTED AND SPIKES WERE FOUND ON THE BLACK CABLE ON CONTROLLER, ON THE WHITE CABLE OF THE OTHER CONTROLLER, AND ON THE MPU. THE PATIENT STAYED ON BATTERIES, WHILE THE CONTROLLERS AND MPU WERE EXCHANGED. THE CAUSE OF THE ALARMS WERE IDENTIFIED TO BE INCORRECT CORRECTIONS DUE TO THE SPIKES ON THE CONTROLLER CABLE. EXCHANGING BOTH SYSTEM CONTROLLERS AND THE MPU RESOLVED THE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398311 HEARTMATE MOBILE POWER UNIT, EU VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION L107758 7832156 00813024010890

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male