BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9659708 · Received February 3, 2020

    Report

    Report Number
    2916596-2020-00520
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    November 20, 2019
    Report Date
    March 16, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE MPU WAS RETURNED FOR EVALUATION DUE TO REPORTED ALARMS FROM THE PATIENT¿S SYSTEM CONTROLLER. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO THE SYSTEM CONTROLLER AND THE OTHER MPU ASSOCIATED WITH THIS COMPLAINT, AND WAS UNRELATED TO THIS MPU. THE RETURNED MPU WAS FUNCTIONALLY TESTED ON (B)(6) 2020 AND WAS FOUND TO PERFORM AS INTENDED. DURING EVALUATION, DAMAGE TO THE MPU¿S PATIENT CABLE WAS OBSERVED. THE CABLE WAS REPLACED WITH A NEW COMPONENT AND THE DAMAGED CABLE WAS SENT TO THE PPE DEPARTMENT FOR FURTHER ANALYSIS. THE RETURNED MPU PATIENT CABLE WAS OBSERVED TO HAVE MANY SMALL CUTS ON ITS CABLE JACKET UPON ARRIVAL. THE CABLE WAS FUNCTIONALLY TESTED USING TEST EQUIPMENT AND THE CABLE FUNCTIONED AS INTENDED, EVEN WHEN HEAVILY MANIPULATED BY HAND. THE ROOT CAUSE OF THE DAMAGE TO THE PATIENT CABLE WAS UNABLE TO BE DETERMINED THROUGH THIS ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE. PMA/510(K) #: P160054. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOBILE POWER UNIT (MPU) WAS IN USE BY THE PATIENT UNTIL RECEIVING INFORMATION REGARDING HER MPU SENT BACK THE SECOND TIME. THE HOSPITAL PROVIDED A LOANER MPU AFTER HAVING SIMILAR REPORTED ISSUES WITH THE DEVICE WITH NO EXTERNAL POWER AND HAVING ISSUES ON THE MPU WHEN CONNECTED AT HOME AS DESCRIBED IN THE PREVIOUS EMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120704 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention