BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2050944 · Received April 4, 2011

    Report

    Report Number
    2916596-2011-00133
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    January 21, 2010
    Report Date
    March 14, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF THE SYSTEM CONTROLLER ALARMING WAS CONFIRMED DURING ANALYSIS. THE BLACK POWER CABLE WAS FOUND TO HAVE A COMPROMISED WIRE AT THE CONNECTOR END. THIS WIRE IS RESPONSIBLE FOR MONITORING BATTERY POWER. THE LOG FILE WAS REVIEWED AS PART OF THE INVESTIGATION AND THE DATA RECORDED WAS CONSISTENT WITH THE REPORTED EVENT. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS SYSTEM CONTROLLER SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE PERFUSIONIST REPORTED THAT THE PATIENT WAS HAVING LOW VOLTAGE ADVISORY ALARMS WHILE ON MULTIPLE BATTERIES AND BATTERY CLIPS. 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 CORP. 103696 88910

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other