BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOMPAC

    MDR report key: 294497 · Received August 30, 2000

    Report

    Report Number
    6000002-2000-00242
    Event Type
    Other
    Date Received
    August 30, 2000
    Date of Event
    August 2, 2000
    Report Date
    August 2, 2000
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RETROGUARD TUBING CONNECTION CAME LOOSE DURING BYPASS, LOST 1500ML OF BLOOD. RESULTED IN ONE UNIT OF BLOOD BEING TRANSFUSED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOMPAC CUSTOMPAC DWE BAXTER HEALTHCARE CORP. C2240M1B UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention