BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSR-4000 GOLD

    MDR report key: 127696 · Received October 17, 1997

    Report

    Report Number
    6000002-1997-00771
    Event Type
    Malfunction
    Date Received
    October 17, 1997
    Report Date
    October 2, 1997
    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

    DURING RECIRCULATION, BLOOD OUTLET PORT OF THE VENOUS RESERVOIR WAS DETACHED. THERE WAS NO PT INJURY OR INTERVENTION REPORTED AS THE RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HSR-4000 GOLD VENOUS RESERVOIR DTN BAXTER HEALTHCARE CORP. HSR-4000 GOLD PP7C2460

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other