BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSR-4000

    MDR report key: 140283 · Received December 23, 1997

    Report

    Report Number
    6000002-1997-00849
    Event Type
    Malfunction
    Date Received
    December 23, 1997
    Date of Event
    November 23, 1997
    Report Date
    November 24, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AFTER 85 MINTUES ON BYPASS THE OUTLET CONNECTOR OF THE VENOUS RESERVOIR DETACHED. NO PT ISSUES WERE REPORTED AS A 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 PP662455

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other