BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAT EXCHANGE SET

    MDR report key: 234966 · Received August 3, 1999

    Report

    Report Number
    234966
    Event Type
    Malfunction
    Date Received
    August 3, 1999
    Date of Event
    July 28, 1999
    Report Date
    August 3, 1999
    Manufacturer
    MALLINCKRODT CO. CRITICAL CARE DIVISION
    Product Code
    BSB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CASSETTE TO BLOOD/FLUID WARMER LEAKED & 200CC AUTOLOGOUS BLOOD WENT ON THE FLOOR. PT UNABLE TO RECEIVE ALL NEEDED AUTOLOGOUS BLOOD DONATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEAT EXCHANGE SET HEC-40 BSB MALLINCKRODT CO. CRITICAL CARE DIVISION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other