BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3915612 · Received June 11, 2014

    Report

    Report Number
    2916596-2014-00966
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    December 12, 2013
    Report Date
    May 15, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVAL. DURING THE ANALYSIS OF THE SYSTEM CONTROLLER THE SYSTEM CONTROLLER COULD NOT OPERATE THE TEST PUMP AND A RED HEART ALARM OCCURRED. A DAMAGED USE ON THE MAIN PRINTED CIRCUIT BOARD (PCB) OF THE SYSTEM CONTROLLER WAS FOUND. THIS FUSE IS ASSOCIATED WITH THE 5 VOLT REGULATOR THAT PROVIDES THE SUPPLY VOLTAGE TO THE OTHER COMPONENTS/CIRCUITRY AND THE ABILITY TO COLLECT THE LOG FILE. THE DAMAGED FUSE PREVENTED THE SYSTEM CONTROLLER TO OPERATE THE PUMP. THE ROOT CAUSE THAT CONTRIBUTED TO THE DAMAGED COMPONENT WAS UNABLE TO BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFO IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD); IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT EXPERIENCED A RED HEART ALARM WITH A LOW CELL BATTERY WHILE SHE WAS OUTSIDE. THE PT FELT FINE AND WHEN SHE GOT BACK TO HER HOUSE SHE HOOKED UP TO THE POWER MODULE AND THE VAD PARAMETERS WERE UNCHANGED. THE VAD COORDINATOR HAD THE PT EXCHANGE THE SYSTEM CONTROLLER AND COME TO THE CLINIC. THE PT'S EVENT HISTORY SHOWED ONE DATE AND NO NUMBERS FOR 120 EVENTS. THE PT DID NOT HAVE ANY SYMPTOMS DURING THE RED HEART ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343845 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other