BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, EU

    MDR report key: 21076238 · Received January 5, 2025

    Report

    Report Number
    2916596-2024-52676
    Event Type
    Malfunction
    Date Received
    January 5, 2025
    Date of Event
    December 10, 2024
    Report Date
    March 27, 2025
    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 DAMAGED MOBILE POWER UNIT (MPU) PATIENT CABLE WAS CONFIRMED. THE MOBILE POWER UNIT SERIAL NUMBER (B)(6) WAS SERVICED AT EDC SERVICE CENTER. VISUAL INSPECTION REVEALED CUTS IN THE PATIENT CABLE. THE DAMAGED PATIENT CABLE WAS REPLACED. THE MPU WAS FUNCTIONALLY TESTED PER THE PROCEDURE AND PASSED ALL TEST STEPS. FURTHER EVALUATION OF THE CABLE, PERFORMED AT PPE (PRODUCT PERFORMANCE ENGINEERING) GROUP CONFIRMED A DAMAGE TO THE PATIENT CABLE WITH EXPOSED AND COMPROMISED ORANGE (POSITIVE POWER LINE), RED (ECHO LINE) AND BLUE (NEGATIVE POWER LINE) INNER WIRES. FURTHER MEASUREMENTS CONFIRMED AN ELECTRICAL CONTACT BETWEEN THE COMPROMISED WIRES AND THE SHIELD. THE CABLE WAS INSTALLED INTO A TEST MOBILE POWER UNIT (MPU) AND THE MPU WAS ALARMING AND RESTARTING AS A RESULT OF THE ELECTRICAL CONTACT BETWEEN THE COMPROMISED WIRES (POSITIVE POWER LINE AND ECHO LINE) AND THE SHIELD. THE INVESTIGATION WAS UNABLE TO DETERMINE THE SPECIFIC ROT CAUSE FOR THE DAMAGED CABLE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE MPU WAS MANUFACTURED IN ACCORDANCE WITH MFG AND QA SPECIFICATIONS. HEARTMATE 3 PATIENT HANDBOOK REV G, SECTION 6 ENTITLED ¿EQUIPMENT MAINTENANCE¿ (STORING 6-3 AND CLEANING AND MAINTAINING THE EQUIPMENT 6-4) AND INSTRUCTION FOR USE REV G, SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ ADDRESS HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE THE EQUIPMENT FOR PROPER USE. HEARTMATE 3 PATIENT HANDBOOK REV G AND INSTRUCTION FOR USE REV G 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    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 HAD A BROKEN CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949447 HEARTMATE MOBILE POWER UNIT, EU VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 107758 7866728 00813024010890

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown