BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSR-4000

    MDR report key: 161445 · Received April 3, 1998

    Report

    Report Number
    6000002-1998-00067
    Event Type
    Malfunction
    Date Received
    April 3, 1998
    Date of Event
    March 9, 1998
    Report Date
    March 11, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING REWARMING, THE SOUND OF BLOOD ON THE FLOOR WAS HEARD. THE PERFUSIONINT LOOKED AT THE VENOUS RESERVOIR PORT AND FOUND THAT IT HAD POPPED OFF. THE CONNECTOR WAS IMMEDIATELY RECONNECTED IN A STERILE MANNER. THE RESERVOIR WAS REPLACED WITHOUT DETRIMENT TO THE PT. 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 PP5E1952

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other