BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3072704 · Received April 23, 2013

    Report

    Report Number
    3072704
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 13, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED ON (B)(6) WITH REPEAT HEMOLYSIS AND DARK TEA COLORED URINE. PT STARTED ON HEPARIN GTT AND INTEGRILIN GTT. LDH 2408 AND HGB-PF 65. PT'S LABS TRENDED DOWN, BUT STILL WITH SIGNS OF HEMOLYSIS. DECISION WAS MADE TO CHANGE OUT THE PUMP ON (B)(6) 2013

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175119 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1