BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV TUBING

    MDR report key: 13223 · Received May 12, 1994

    Report

    Report Number
    MW1001962
    Event Type
    Malfunction
    Date Received
    May 12, 1994
    Date of Event
    May 3, 1994
    Report Date
    May 9, 1994
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED DOUBLE BOLUS OF ACTIVASE AS A RESULT OF ANOTHER CO'S PUMP FAILURE SECONDARY TO PUNCTURE IN CO'S IV TUBING. FIRST MACHINE BOLUSED; TUBING CHANGED AND MACHINE WOULD NOT WORK; MACHINE CHANGED AND THEN SECOND BOLUS WAS GIVEN. PUMP READ FALSE OCCLUSION SECONDARY TO WET ULTRASONIC DETECTOR. (ALSO SEE 1001961.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IV TUBING IV TUBING FPA BAXTER HEALTHCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR