BEUDAMED
    FDA Adverse Event Other Summary report: N

    XX PE ADULT-PED WET W/CF LF

    MDR report key: 421291 · Received October 10, 2002

    Report

    Report Number
    1221601-2002-00021
    Event Type
    Other
    Date Received
    October 10, 2002
    Report Date
    October 10, 2002
    Manufacturer
    GENZYME BIOSURGERY A DIVISION OF GE
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE UNIT ALLEGEDLY WOULD NOT DRAIN INTO THE SECOND CHAMBER AND FLUID WOULD THEN BACK UP TOWARDS THE PT. THE CUSTOMER HAS THROWN THE UNITS AWAY BECAUSE THEY WERE CONTAMINATED, HOWEVER THEY WILL BE RETURNING SOME UNUSED UNITS FROM THE SAME LOT. THE UNIT WAS REPLACED WITHOUT ISSUE. THERE WAS NO PT INJURY REPORTED. THE SALES REP REPORTED THAT THE ACCOUNT HAS NOT UTILIZED AUTOTRANSFUSION FOR TWO YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XX PE ADULT-PED WET W/CF LF CHEST DRAINAGE DEVICE CAC GENZYME BIOSURGERY A DIVISION OF GE A-9350LF 329962

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other