BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSTAVAC

    MDR report key: 93278 · Received May 23, 1997

    Report

    Report Number
    1811755-1997-00044
    Event Type
    Death
    Date Received
    May 23, 1997
    Date of Event
    August 22, 1996
    Report Date
    April 15, 1997
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED CELL SAVER INFUSION FOR LOW BLOOD PRESSURE 80/40 IN OR S/P BILATERAL KNEE REPLACEMENT. TWENTY MINUTES POST-OPERATIVELY, PT ARRESTED. AUTOPSY REPORT SHOWED MICROSCOPIC FAT AND BONE MARROW CAUSED PULMONARY EMBOLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTAVAC BLOOD REINFUSER CAC STRYKER INSTRUMENTS 0215-028-000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death