BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSR-4000

    MDR report key: 224053 · Received May 13, 1999

    Report

    Report Number
    6000002-1999-00133
    Event Type
    Malfunction
    Date Received
    May 13, 1999
    Date of Event
    April 6, 1999
    Report Date
    April 15, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BLOOD OUTLET CONNECTOR, WHICH IS GLUED TO THE MAIN BODY OF THE RESERVOIR BECAME SEPARATED DURING CARDIOPULMONARY BYPASS. MASSIVE BLOOD LOSS FROM THE RESERVOIR AND CARDIOPULMONARY BYPASS WAS INTERUPTED. NO PERMANENT PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HSR-4000 VENOUS RESERVOIR DTN BAXTER HEALTHCARE CORP. HSR-4000 PP7D2832

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other