BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELL SAVER

    MDR report key: 542573 · Received September 2, 2004

    Report

    Report Number
    1219343-2004-00002
    Event Type
    Death
    Date Received
    September 2, 2004
    Date of Event
    August 2, 2004
    Report Date
    September 2, 2004
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AUTOTRANSFUSION SERVICE REPORTED PT DEATH. REPORT WAS FROM SERVICE'S CUSTOMER. DEATH WAS REPORTED TO BE FROM AIR EMBOLISM CAUSED BY PRESSURE REINFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL SAVER AUTOTRANSFUSION DEVICE CAC HAEMONETICS CORP. CELL SAVER 3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death