BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3131360 · Received May 23, 2013

    Report

    Report Number
    2916596-2013-00651
    Event Type
    Death
    Date Received
    May 23, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 26, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE HOSPITAL'S BIOMEDICAL ENGINEER THAT THE PUMP WAS NOT RETRIEVED AND WILL NOT BE RETURNING TO THE MFR FOR EVAL AS THE FAMILY DID NOT CONSENT TO AN AUTOPSY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MFR RECEIVED THE USER FACILITY REPORT ((B)(4)) FROM THE (B)(4) REGISTRY. THE REPORT INDICATED THAT THE PT WAS ADMITTED TO THE HOSPITAL WITH SIGNS OF HEMOLYSIS. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED. THROMBUS COULD NOT BE RULED OUT IN THE PUMP. THE PT WAS STARTED ON HEPARIN AND BRIDGED TO COUMADIN. THE PT EXPIRED 10 DAYS LATER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HOSPITAL'S NURSE THAT WHEN THE PT WAS ADMITTED, SHE COMPLETED AND EXIT SITE DRESSING SHE HAD PLACED 3 WEEKS PRIOR. THE PT ADMITTED TO NOT CHANGING THE DRESSING DURING THAT PERIOD. THE EXIT SITE WAS RED, PAINFUL WITH PURULENT DRAINING COMING FROM THE SITE WITH DRIED PURULENT DRAINAGE ALSO BEING PRESENT. THE NURSE REPORTED THAT THE PT EXPIRED DUE TO SEPSIS FROM NONCOMPLIANCE WITH DRESSING CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230478 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 88798

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death