BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 281318 · Received June 7, 2000

    Report

    Report Number
    2916596-2000-00021
    Event Type
    Death
    Date Received
    June 7, 2000
    Date of Event
    May 9, 2000
    Report Date
    May 10, 2000
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A USER INDICATEDONA MEDICAL DEVICE TRACKING FORM THAT A PT WHO WAS BEING SUPPORTED BY A LEFT VENTRICULAR ASSIST DEVICE HAD DIED OF MULTI-ORGAN FAILURE WITH SEVERE HEMOLYSIS. THE TRACKING FORM ALSO INDICATED THAT THE DEVICE MAY HAVE CAUSED PT'S DEATH. F/U CONVERSATIONS WITH THE USER AT THE HOSP DID NOT PROVIDE ANY EVIDENCE OF ANY VENTRICULAR ASSIST DEVICE MALFUNCTION DURING USE THAT MIGHT HAVE LED TO THE HIGH LEVELS OF HEMOLYSIS OBSERVED IN THIS PT. THE F/U INFO DID INDICATE THAT THE PT SUFFERED RENAL FAILURE AND REQUIRED CONTINUOUS VENOUS-VENOUS HEMODIAFILTRATION (CVVH) THROUGHOUT THE ENTIRE DURATION OF VENTRICULAR ASSIST DEVICE SUPPORT (77 DAYS). ROLLER PUMPS AND INFUSIONS PORTS USED FOR CVVH ARE WELL KNOWN SOURCES OF HEMOLYSIS. THE DEVICE WAS RETURNED TO THORATEC FOR INVESTIGATION, WHERE IT WAS FOUND TO BE TOTALLY UNREMARKABLE. THORATEC HAS NEVER REC'D ANY PREVIOUS REPORTS OF PT DEATH DUE TO HEMOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM VENTRICULAR ASSIST DEVICE (VAD) BLOOD PUMP DSQ THORATEC LABORATORIES CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death (2/23/2000 TO 2000)| CONTINUOUS VENOUS-VENOUS HEMODIAFILTRATION,