BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVASE

    MDR report key: 4100876 · Received September 12, 2014

    Report

    Report Number
    2916596-2014-01593
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 12, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS ADMITTED FOR HEMATURIA. LACTATE DEHYDROGENASE (LDH) 5119 AND PLASMA-FREE HEMOGOBLIN (PHGB) 102 ON (B)(6) 2014. NO POWER ELEVATIONS WERE NOTED. THE AORTIC VALVE OCCASIONALLY OPENS ON ECHO. ON HEPARIN GTT AT 1500 UNITS/HR WITH IV FLUIDS AND LACTATE DEHYDROGENASE (LDH) 4000 AS OF (B)(6) 2014. THE PATIENT CONTINUES TO HAVE HEMOLYSIS ON HEPARIN WITH LACTATE DEHYDROGENASE 5100. NO HEMATURIA OR POWER ELEVATIONS AND CREATINE INCREASED SLIGHTLY. THE PUMP WAS EXPLANTED (B)(6) 2014 AND WILL BE RETURNED. THE PATIENT WAS EXCHANGED TO ANOTHER MANUFACTURE'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565796 HEARTMATE II LVASE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 118682

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention