BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1960336 · Received December 15, 2010

    Report

    Report Number
    2916596-2010-00345
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 24, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF LOW VOLTAGE ALARMS WAS CONFIRMED AND REPRODUCED DURING ANALYSIS. THE BLACK POWER CABLE WAS FOUND TO HAVE MULTIPLE COMPROMISED CONDUCTORS AT THE CONNECTOR END. THE YELLOW (ALARM OUT), ORANGE (TRANSMIT COMMUNICATION), AND BROWN (RSOC) INNER CONDUCTORS WERE FOUND TO BE COMPROMISED. THE DAMAGE TO THE CONDUCTORS DID NOT AFFECT THE FUNCTION OF THE PUMP DURING ANALYSIS; HOWEVER, MOVEMENT OF THE CABLE AT THE CONNECTOR END CAUSED LOW POWER ALARMS. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS SYSTEM CONTROLLER SHOWED NO DEVIATIONS FROM MFG OR QA SPECS. THIS SITUATION IS BEING ADDRESSED THROUGH THE MFR'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE PERFUSIONIST REPORTED THAT THE PT WAS HAVING LOW VOLTAGE ALARMS. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 103696 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other