BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE POWER MODULE PATIENT CABLE, 14 VOLT

    MDR report key: 10460604 · Received August 27, 2020

    Report

    Report Number
    2916596-2020-04053
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    July 23, 2020
    Report Date
    October 26, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010784
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A: PATIENT INFORMATION WAS INADVERTENTLY INCLUDED IN THE INITIAL REPORT. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A BENT PIN WAS CONFIRMED WITH THE RETURNED 14V POWER MODULE PATIENT CABLE (LOT # 11019042903). VISUAL INSPECTION OF THE RETURNED PRODUCT REVEAL BENT PIN WITHIN THE POWER MODULE CONNECTOR END OF THE CABLE, WHICH WAS PREVENTING A FULLY SEATED CONNECTION TO THE POWER MODULE. THE BENT PIN WAS STRAIGHTENED AND WAS FUNCTIONALLY TESTED USING LABORATORY EQUIPMENT, WHICH DID NOT REVEAL ANY FUNCTIONAL ISSUE AFTER REPAIR. ALTHOUGH THE ROOT CAUSE OF THIS DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED, IT APPEARED TO BE A RESULT OF PHYSICALLY MATING THE TWO PARTS. 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 WHILE CHANGING THE POWER SOURCE, THE POWER CABLE DISCONNECT ALARM DID NOT GO AWAY AFTER THE POWER CABLES WERE RECONNECTED. UPON INSPECTION IN THE HOSPITAL, THE ENGINEER FOUND THE A BENDED PIN IN THE PATIENT CABLE. THE CABLE WAS REPLACED AND THE PATIENT WAS ISSUED A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925110 HEARTMATE POWER MODULE PATIENT CABLE, 14 VOLT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 103426 11019042903 00813024010784

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention