BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSR-4000

    MDR report key: 140647 · Received December 23, 1997

    Report

    Report Number
    6000002-1997-00850
    Event Type
    Malfunction
    Date Received
    December 23, 1997
    Date of Event
    November 23, 1997
    Report Date
    November 23, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AT THE END OF BYPASS, WHEN THE LAST 100 CC'S OF BLOOD WERE BEING GIVEN BACK TO THE PT, THE CONNECTOR OF THE VENOUS RESERVOIR FELL OFF. 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 PP6G2352

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other