BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, EU

    MDR report key: 23656589 · Received November 26, 2025

    Report

    Report Number
    2916596-2025-07675
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 24, 2025
    Report Date
    January 27, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010890
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A BROKEN MOBILE POWER UNIT (MPU) PATIENT CABLE WAS CONFIRMED DURING EVALUATION OF THE RETURNED HEARTMATE MPU. THE MPU, SERIAL NUMBER (B)(6), WAS EVALUATED AT THE EUROPEAN DISTRIBUTION CENTER (EDC) SERVICE CENTER ON 05DEC2025. THE UNIT WAS CONNECTED TO AC POWER AND A BLINKING YELLOW WRENCH SYMBOL WAS ACTIVATED. THE ISSUE WAS TRACED TO THE DAMAGED MPU PATIENT CABLE. THE PATIENT CABLE WAS REPLACED AND THE UNIT PASSED FUNCTIONAL TESTING. THE MPU WAS DEEMED READY FOR USE AND THE MPU PATIENT CABLE WAS FORWARDED TO THE PRODUCT PERFORMANCE ENGINEERING (PPE) DEPARTMENT. THE MPU PATIENT CABLE WAS CONNECTED TO A KNOWN WORKING MPU TEST FIXTURE. THE BLINKING YELLOW WRENCH SYMBOL ACTIVATED UPON BEING POWERED UP. EVALUATION OF THE MPU PATIENT CABLE REVEALED DAMAGE TO THE INTERNAL BLACK, YELLOW AND WHITE WIRES. THIS DAMAGE WAS FOUND TO BE CAUSE OF THE YELLOW WRENCH SYMBOL THAT WAS ACTIVATING ON THE MPU. THE ROOT CAUSE OF THE DAMAGED MPU PATIENT CABLE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. INCIDENTAL FINDINGS: LOOSE MPU PATIENT CABLE CONNECTOR CASING. CRACKED BATTERY DOOR. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8 ¿ ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6 ¿ ¿CARING FOR EQUIPMENT¿ EXPLAIN HOW TO PROPERLY CARE FOR THE EQUIPMENT, INCLUDING THE MPU PATIENT CABLE. HEARTMATE 3 PATIENT HANDBOOK SECTION 6 ¿ "CARING FOR THE EQUIPMENT" DESCRIBES HOW TO CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE MPU PATIENT CABLE. SECTION 10, ENTITLED ¿SAFETY CHECKLISTS¿, PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD, INCLUDING INSPECTING THE MPU FOR DAMAGE. THIS SECTION ALSO INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. THE PATIENT HANDBOOK AND THE INSTRUCTIONS FOR USE CAUTION THE USER 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    G3: THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THE PMA# PROVIDED IS ASSOCIATED WITH MOST RECENT APPROVAL. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MOBILE POWER UNIT (MPU) HAD A BROKEN CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255164 HEARTMATE MOBILE POWER UNIT, EU VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 107758 7075300 00813024010890

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown