BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK/CONTINU-FLO/DUO-VENT

    MDR report key: 15282451 · Received August 24, 2022

    Report

    Report Number
    15282451
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    January 4, 2022
    Report Date
    August 5, 2022
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HEALTH CARE PROVIDER TOOK OVER A PATIENT ASSIGNMENT FOR ONE OF THE FLOOR REGISTERED NURSES (RNS). RN REPORTED TO HEALTH CARE PROVIDER THAT SHE HAD TO RETURNED THE TAXOL TO PHARMACY BECAUSE SHE DID SEE ONE DROP OF LIQUID ON THE FILTER. SHE WAS NOT 100% SURE IF THERE WAS A LEAK BUT ASKED PHARMACY TO EXCHANGE THE TUBING. HEALTH CARE PROVIDER CALLED THE PHARMACY AND THEY INFORMED ME THAT THEY EXAMINED THE TUBING AND THEY DID NOT FIND A LEAK SO IT WAS RETURNED TO THE BIN FOR ADMINISTRATION. I HUNG THE TAXOL. ABOUT HALF WAY THROUGH THE INFUSION I REALIZED THE LEAK HAD RETURNED AT THE SITE OF THE FILTER. FILTER WAS SITTING ON THE PATIENT SIDE TABLE SO WAS RELATIVELY CONTAINED AND NONE OF THE MEDICATION LEAKED ON TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163779 CLEARLINK/CONTINU-FLO/DUO-VENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER INTERNATIONAL INC. 2C8541

    Patients

    Seq Age Sex Outcome Treatment
    1 22265 DA Male