BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE STROKE VOLUME LIMITER

    MDR report key: 1311811 · Received February 10, 2009

    Report

    Report Number
    2916596-2009-00032
    Event Type
    Death
    Date Received
    February 10, 2009
    Date of Event
    December 3, 2008
    Report Date
    January 13, 2009
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CORRESPONDENCE RECEIVED FROM THE USER FACILITY ON 1/28/09, STATED THAT WHEN THE STROKE VOLUME LIMITER (SVL) WAS REMOVED AFTER THE PT'S DEATH, THE O-RING FROM THE MEDICAL COUPLING AREA OF THE SVL HAD BROKEN OFF AND WAS THROWN AWAY. THE O-RING WAS REPLACED AND THE SVL WAS RETURNED TO THE MFR WITH A NEW O-RING. OUR PHYSICAL EXAMINATION OF THE SVL DID NOT REVEAL ANY MFG RELATED ISSUES OR MATERIAL DEFECTS. THE SVL WAS LEAK TESTED FOR POTENTIAL AIR LEAKS, AND NO LEAK ISSUES WERE NOTED. THE SVL WAS ALSO FUNCTIONALLY TESTED UNDER LOADED CONDITIONS, AND THE UNIT WAS FOUND TO OPERATE AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MFG OR QA SPECS. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE DESTINATION THERAPY PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PT EXPIRED IN '08 (REFERENCE MFR REPORT # 2916596-2008-00183). A USER FACILITY REPORT WAS RECEIVED ON 1/13/09, AND BASED ON THE INFO PROVIDED, THE STROKE VOLUME LIMITER (SVL) WAS NOT FILLING COMPLETELY; THEREFORE, VENTING OF THE SVL WAS PERFORMED, AND THE PT STATED HE FELT FUNNY. FIVE MINUTES LATER, THE SVL WAS CHECKED AGAIN, AND WAS NOT COMPLETELY FILLING. A SECOND VENTING OF THE SVL WAS PERFORMED AND THE PT THEN PASSED OUT. THE SVL AND DRIVE CONSOLE WERE EXCHANGED, AND THE NEW SVL AND DRIVE CONSOLE WERE VENTED, AND COMPLETELY FILLED AND EMPTIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE STROKE VOLUME LIMITER STROKE VOLUME LIMITER DSQ THORATEC CORP. 1295 29015

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death