BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 12897475 · Received November 30, 2021

    Report

    Report Number
    2916596-2021-07056
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    July 13, 2021
    Report Date
    November 30, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT'S DEATH IS REPORTED UNDER MFR # 2916596-2021-05064. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT, OF A DISCOLORED MPU PATIENT CABLE, WAS CONFIRMED WHEN THE UNIT WAS EVALUATED BY DEPOT SERVICES. THE UNIT WAS REPAIRED BY REPLACING THE MPU PATIENT CABLE. THE REPAIRED MPU WAS TESTED AND RETURNED TO THE RENTAL/LOANER POOL. THE PATIENT CABLE WAS OPERATIONAL WHEN CHECKED WITH THE RETURNED MPU. THERE WERE NO OTHER OBVIOUS DAMAGE TO THE OUTER JACKET OF THE CABLE. THE MPU UNIT WAS ALMOST 4 YEARS OLD. THE ROOT CAUSE OF THE DISCOLORATION WAS NOT DETERMINED IN THIS INVESTIGATION. THE MPU ASSEMBLY (PN 108285) WAS MADE DEC 9, 2016. THE MPU UNIT WAS PACKAGED (PN 107754) AND PLACED INTO STOCK ON DEC 23, 2016. THE UNIT WAS RETURNED SENT TO THE CUSTOMER ON JAN 9, 2017. THE UNIT WAS ASSIGNED TO THE PATIENT ON (B)(6) 2017. THE UNIT HAD NO PREVIOUS SERVICES. SET UP AND USE OF THE MOBILE POWER UNIT (MPU) ARE DOCUMENTED IN THE HEARTMATE II LVAS PATIENT HANDBOOK. SPECIFIC WARNINGS AND CAUTIONS REGARDING THE MPU'S SET UP, THE POTENTIAL TRIPPING HAZARDS PRESENTED BY THE MPU PATIENT CABLE AND POWER CORD, AND THE ELECTRICAL OUTLET USED (INCLUDING LOCATION AND ACCESSIBILITY) ARE GIVEN IN THE HEARTMATE II LVAS PATIENT HANDBOOK. MAINTENANCE AND PERIODIC CLEANING OF THE MPU ARE DOCUMENTED IN THE HEARTMATE II LVAS PATIENT HANDBOOK ¿ MPU MAINTENANCE- CARING FOR THE MPU AND ¿ SAFETY CHECKLIST. THE HEARTMATE II LVAS PATIENT HANDBOOK STATES THAT THE PATIENT SHOULD CONTACT THEIR HOSPITAL SHOULD THEY BELIEVE THEIR EQUIPMENT HAS ISSUES - "IF 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". NO FURTHER INFORMATION PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S MOBILE POWER UNIT (MPU) WAS RETURNED FOR EVALUATION FOLLOWING THE PATIENT'S DEATH. THROUGH THE INVESTIGATION, THE PRODUCT HAD CONFIRMED DAMAGE. THE MPU HAD A DISCOLORED PATIENT CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797492 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION L107754TS 8136397 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male