BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE EMERGENCY POWER PACK

    MDR report key: 857795 · Received May 31, 2007

    Report

    Report Number
    2916596-2007-00091
    Event Type
    Malfunction
    Date Received
    May 31, 2007
    Date of Event
    May 2, 2007
    Report Date
    May 24, 2007
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE REPORTED EVENT WAS CONFIRMED. THE EVALUATION OF THE EMERGENCY POWER PACK (EPP) REVEALED A BROKEN BATTERY TERMINAL BETWEEN THE EPP AND THE PCB RESULTING IN LOSS OF POWER TO THE WHITE POWER LEAD. SUBSEQUENT EVALUATION OF THE BROKEN BATTERY TERMINAL REVEALED THE SOLDER CONNECTION OF THE PCB WIRE TO THE TERMINAL WAS INTACT; HOWEVER, IT APPEARED THAT THE TERMINAL WAS FRACTURED ADJACENT TO THE SOLDER JOINT CONSISTENT TO DAMAGE RESULTING IN EXCESS MOVEMENT OR FLEXING. THE EVALUATION COULD NOT CONCLUSIVELY DETERMINE IF THE BATTERY TERMINAL DAMAGE OCCURRED DURING USE OR POTENTIALLY DURING THE ASSEMBLY PROCESS. A REVIEW OF DEVICE HISTORY RECORDS SHOWED THERE WERE NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE VAD COORDINATOR THAT WHILE THE PATIENT WAS AWAY FROM HOME AND ON PORTABLE BATTERY POWER, SHE RAN OUT OF POWER. SHE CONNECTED TO HER EMERGENCY POWER PACK (EPP) AND EXPERIENCED A FLASHING GREEN LIGHT ON THE CONTROLLER AND AN AUDIBLE TONE. THE PATIENT WENT TO THE HOSPITAL, AND THE VAD COORDINATOR DISCONNECTED THE BLACK LEAD FROM THE EPP AT WHICH TIME THE PUMP LOST POWER. PATIENT WAS THEN PLACED ON PORTABLE BATTERIES WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE EMERGENCY POWER PACK EMERGENCY BATTERY PACK DSQ THORATEC CORPORATION 2020 55474

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention