BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2180749 · Received May 5, 2011

    Report

    Report Number
    2916596-2011-00184
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 7, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-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 OF RED HEART ALARMS WAS CONFIRMED BASED ON INVESTIGATION FINDINGS. THE ANALYSIS OF THE BLACK POWER CABLE REVEALED A COMPROMISED BROWN INNER CONDUCTOR AT THE CONNECTOR END. MANIPULATING THE BLACK CONNECTOR CAUSED RED HEART ALARM CONDITIONS THAT WERE OBSERVED DURING ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURE'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMER. NO FURTHER INFO 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 (LVAD). THE SURGEON REPORTED THAT WHILE THE PT WAS AT HOME PREPARING HIMSELF TO GO TO BED, THE SYSTEM CONTROLLER DEMONSTRATED RED HEART ALARMS. WHEN THE ALARM WAS ACTIVATED, THE PT WAS ON HIS POWER MODULE FOR A SHORT PERIOD OF TIME. THE PT IMMEDIATELY CHECKED THE CONNECTIONS TO THE PUMP AND THE POWER MODULE AND EVERYTHING LOOKED JUST FINE. THE PT DECIDED TO SWITCH TO HIS BACKUP CONTROLLER. THE SUSPECT SYSTEM CONTROLLER WAS EXCHANGED PER THE MFR'S INSTRUCTIONS FOR USE AND THE PT REMAINS ONGOING ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other