BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTRANSFUSION(ATS) REPLACEMENT BAG

    MDR report key: 218057 · Received April 8, 1999

    Report

    Report Number
    1221601-1999-00002
    Event Type
    Malfunction
    Date Received
    April 8, 1999
    Date of Event
    March 4, 1999
    Report Date
    April 6, 1999
    Manufacturer
    GENZYME SURGICAL PRODUCTS CORP.
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOTICED BUBBLING IN WATER SEAL OF A PLEUR-EVAC ON A NEW HEART PT; THEN BLOOD BEGAN TO LEAK FROM ATS BAG, AT SEAMS OF BAG. THE ATS BAG WAS CHANGED AND ALL WAS THEN FINE. HOSPITAL HAS BEEN USING PLEUR-EVAC FOR 11 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTRANSFUSION(ATS) REPLACEMENT BAG ATS CHEST DRAINAGE SYS CAC GENZYME SURGICAL PRODUCTS CORP. A-1500 309601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN