BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 10567158 · Received September 22, 2020

    Report

    Report Number
    2916596-2020-04563
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    September 2, 2020
    Report Date
    January 22, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DAMAGE ON THE PATIENT CABLE WAS CONFIRMED WITH THE RETURNED MOBILE POWER UNIT (SERIAL # (B)(6). VISUAL INSPECTION OF THE RECEIVED PART CONFIRMED DEFORMATION OF THE OUTER INSULATION THAT APPEARS TO HAVE BEEN INDUCED BY HIGH TEMPERATURE. ELECTRICAL TESTING OF THE PATIENT CABLE PORTION DID NOT REVEAL ANY SHORTED OR SEVERED CONDITION WITH THE UNDERLYING WIRES. THE DAMAGED AREA WAS DISSECTED, AND VISUAL INSPECTION REVEALED NO DAMAGE TO UNDERLYING WIRES. THE ANALYSIS COULD NOT DETERMINE A ROOT CAUSE OF THE DAMAGE ON THE PATIENT CABLE. DEVICE HISTORY RECORD INDICATED THE DEVICE WAS MANUFACTURED IN ACCORDANCE TO MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS. MOBILE POWER UNIT (SERIAL # (B)(6) WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2020. THE HEARTMATE 3 PATIENT HANDBOOK CAUTIONS THE USERS TO ¿CALL YOUR HOSPITAL CONTACT IF YOU THINK THAT, FOR ANY REASON, ANY PORTION OF YOUR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR YOU ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. YOUR HOSPITAL CONTACT CAN CHECK THE EQUIPMENT AND ORDER REPLACEMENTS, IF NEEDED. DO NOT TRY TO REPAIR ANYTHING YOURSELF. UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ ALL ALARM CONDITIONS ARE ADDRESSED. THE HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) STATES ¿REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED. PMA/510(K) #: P160054.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CABLE TO THE MPU HAS AN EXPOSED WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034679 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR