BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE LVAD

    MDR report key: 6046670 · Received October 19, 2016

    Report

    Report Number
    MW5065531
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 19, 2016
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH HMII LVAD ON (B)(6) 2014. PATIENT ADMITTED (B)(6) 2016 WITH SUSPECTED HEMOLYSIS AFTER PRESENTING TO THE ER WITH SOB. DARK URINE, AND ELEVATED HEMOLYSIS LABS. AFTER FAILURE OF ALL OTHER MEDICAL OPTIONS DECISION WAS MADE TO EXCHANGE PUMP ON (B)(6)2016. SURGEON NOTED A SMALL RING THROMBUS ON THE AFT BEARING ON THE VAD PUMP DURING SURGERY. LVAD PUMP WAS EXCHANGED FOR ANOTHER HMII.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693354 HEARTMATE LVAD HMII LVAD PUMP DSQ THORATEC CORP. HMII LVAD PUMP 131763

    Patients

    Seq Age Sex Outcome Treatment
    1