BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER, EU

    MDR report key: 2191574 · Received July 20, 2011

    Report

    Report Number
    2916596-2011-00295
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    April 5, 2011
    Report Date
    June 21, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    2916596/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVAL AND THE REPORTED EVENT WAS CONFIRMED. DURING ANALYSIS, MOVEMENT OF THE WHITE POWER LEAD RESULTED IN ALARMS, INCLUDING THE POWER CABLE DISCONNECT ALARM AS REPORTED. UPON FURTHER INVESTIGATION, THE WHITE POWER LEAD WAS STRIPPED AT THE CONNECTOR END, AND THE BROWN WIRE WAS CONFIRMED TO BE DAMAGED. A SINGLE BROKEN WIRE IN THE POWER LEAD DOES NOT PRESENT A HAZARD IN AND OF ITSELF AS THE WIRES PROVIDING POWER TO THE PUMP ARE REDUNDANT AND THE SIGNALS CARRIED ON THE OTHER WIRES ARE NOT CRITICAL TO MAINTAINING PUMP FUNCTION. A BROKEN WIRE DOES HAVE THE POTENTIAL TO CONTACT THE BRAIDED SHIELDING OF THE POWER LEAD, CREATING A SHORT CIRCUIT WHICH THEN TRIGGERS AN ALARM, MOST FREQUENTLY "RED HEART", "LOW BATTERY", OR "POWER CABLE DISCONNECT" ALARMS AS REPORTED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MFG OR QA SPECIFICATIONS. THIS SITUATION HAS BEEN ADDRESSED THROUGH THE MFR'S CORRECTIVE PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (2916596/2/10001-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 DEVICE. APPROX 6 MONTHS POST-IMPLANT, THE PT REPORTED OCCURRENCES OF POWER CABLE DISCONNECT ALARMS WHILE CONNECTED TO EITHER FULLY CHARGED BATTERIES OR A POWER MODULE. THE SUSPECT SYSTEM CONTROLLER WAS EXCHANGED PER THE MFR'S INSTRUCTIONS FOR USE AND THE PT REMAINS ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER, EU LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103692 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR