BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1023424 · Received April 2, 2008

    Report

    Report Number
    2916596-2008-00041
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS SUCCESSFULLY TRANSPLANTED IN 2008. THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PERFUSIONIST THAT THE PT WAS IN BED WHEN THE CATHETER CAME LOOSE AND URINE WAS RELEASED ONTO THE BED. THE PUMP SUCKED IN URINE AND REVERTED TO BASAL RATE MODE AND THE PT WAS PLACED ON PNEUMATIC SUPPORT USING AN IP CONSOLE AND STROKE VOLUME LIMITER (SVL) AND WAS BEING VENTED EVERY 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE XVE LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1270

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK