BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSR-4000

    MDR report key: 168964 · Received May 12, 1998

    Report

    Report Number
    6000002-1998-00106
    Event Type
    Malfunction
    Date Received
    May 12, 1998
    Report Date
    April 15, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE BLOOD OUTLET CONNECTOR WAS DETACHED JUST BEFORE BYPASS WAS FINISHED. A LITTLE BLOOD WAS REPORTED TO HAVE LEAKED. NO 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 PP6J2361

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other