BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2862348 · Received November 6, 2012

    Report

    Report Number
    2916596-2012-01039
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    September 7, 2012
    Report Date
    October 10, 2012
    Manufacturer
    THORATEC CORP.
    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 REPORTED EVENT OF LOW VOLTAGE ALARMS WAS CONFIRMED AND REPRODUCED DURING ANALYSIS. THE EVAL OF THE RETURNED SYSTEM CONTROLLER REVEALED A DAMAGED/SEVERED INNER CONDUCTOR IN THE BLACK POWER LEAD. MOVEMENT OF THE BLACK POWER CABLE AT THE CONNECTOR END RESULTED IN POWER CABLE DISCONNECT AND LOW BATTERY ALARMS AS WELL AS INTERRUPTION IN PUMP SUPPORT WHILE TETHERED TO THE POWER MODULE. THE LOG FILE WAS RETRIEVED AS PART OF THE INVESTIGATION AND CONTAINED APPROX 7 HRS OF EVENTS, WHERE NUMEROUS ATYPICAL POWER CABLE DISCONNECT AND LOW BATTERY ALARMS WERE RECORDED. SEVERAL LOW SPEED ADVISORY ALARMS WERE ALSO RECORDED ASSOCIATED WITH UNUSUALLY LOW VOLTAGE LEVELS (10.1-13.0 V). 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 HOSP REPORTED THAT THE PT EXPERIENCED MULTIPLE LOW VOLTAGE ADVISORIES, RANDOM BEEPS AT HOME, AND FLASHING GREEN LIGHTS WHEN CONTROLLER HAD ADEQUATE POWER. DURING THE INVESTIGATION OF THE RETURNED SYSTEM CONTROLLER, A BROKEN/SHORTED BROWN WIRE WAS FOUND AND LOW VOLTAGE AND PUMP STOPPED ALARMS AND ATYPICAL EVENTS WERE RECORDED IN THE LOG FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER DSQ: SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 100775

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other