BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3862744 · Received May 22, 2014

    Report

    Report Number
    2916596-2014-00804
    Event Type
    Death
    Date Received
    May 22, 2014
    Date of Event
    April 12, 2014
    Report Date
    April 22, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT EXPIRED. THE HOSPITAL INDICATED THAT THE PUMP WAS NO EXPLANTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A SPECIFIC CAUSE FOR THE REPORTED INFECTION, SUBARACHNOID HEMORRHAGE, AND MULTISYSTEM ORGAN FAILURE COULD NOT BE DETERMINED. AN AUTOPSY WAS NOT PERFORMED AND THE PUMP WAS NOT EXPLANTED. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS DEVICE SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT WAS ADMITTED ON (B)(6) 2014 WITH FEVER DUE TO PERSISTENT PSEUDOMONAS BACTEREMIA. THE PT WAS TREATED WITH ANTIBIOTICS AND TRANSFERRED TO ANOTHER CENTER FOR A SECOND OPINION PER FAMILY REQUEST. THE VAD COORDINATOR WAS NOTIFIED BY THE ACCEPTING CENTER THAT THE PT EXPIRED ON (B)(6) 2014 UNDER THE CARE OF HOSPICE DUE TO SEPSIS WITH MULTI SYSTEM ORGAN FAILURE AND SUBARACHNOID HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306867 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 101798

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death