BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSR-4000

    MDR report key: 122866 · Received September 23, 1997

    Report

    Report Number
    6000002-1997-00728
    Event Type
    Malfunction
    Date Received
    September 23, 1997
    Report Date
    September 16, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING BYPASS, THE OUTLET CONNECTOR OF THE VENOUS RESERVOIR DETACHED. THERE WAS BLOOD LOSS. NO PT ISSUES WERE REPORTED AS THE RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HSR-4000 VENOUS RESERVOIR DTN BAXTER HEALTHCARE CORP. HSR-4000 PP7E2749

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other