BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELL SAVER 3+

    MDR report key: 440538 · Received January 31, 2003

    Report

    Report Number
    1219343-2003-00001
    Event Type
    Death
    Date Received
    January 31, 2003
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DEVICE DISPLAYED AIR DETECTOR MESSAGE DURING AN EMERGENCY PROCEDURE ON A PT WHO SUFFERED 2 GUNSHOT WOUNDS TO THE HEART. PT SUBSEQUENTLY DIED. DEVICE WAS NOT USED ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL SAVER 3+ AUTOTRANS FUSION SYSTEM CAC HAEMONETICS CORP. CS3R *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN