BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK

    MDR report key: 15282476 · Received August 24, 2022

    Report

    Report Number
    15282476
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    February 11, 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

    THESE TWO DESCRIPTIONS WERE SHARED BY TWO SEPARATE INDIVIDUALS THRU OUR INCIDENT REPORT SYSTEM, BUT IT DEPICTS THE ONE EVENT BEING REPORTED. SET UP PACLITAXEL IN THE PUMP TO INFUSION TO THE PATIENT. THE PUMP BEEPED AND NOTIFIED THAT THE INFUSION COULD NOT PROCEED BECAUSE THERE WAS AN OCCLUSION. REGISTERED NURSE (RN) RESTARTED THE INFUSION AND THE PUMP ALARMED AGAIN. RN HAD THE LINE IN HAND NEAR THE FILTER AND FELT A DRIP. RN IMMEDIATELY DISCONNECTED IT FROM THE PATIENT AND BAGGED UP MEDICATION AND IV LINE IN THE APPROPRIATE CHEMO BAG AND RETURNED IT TO PHARMACY. PHARMACY INSPECTED BAG AND IT WAS DETERMINED THAT THERE WAS NO LEAK. SECOND RN THEN HUNG THE CHEMO TO INFUSE AND IT LEAKED FROM THE FILTER. HEALTH CARE PROVIDER TOOK OVER A PATIENT ASSIGNMENT FOR ONE OF THE FLOOR RNS. HEALTH CARE PROVIDER REPORTED TO SUPERVISOR THAT SHE HAD TO RETURNED THE TAXOL TO PHARMACY BECAUSE SHE DID SEE ONE DROP OF LIQUID ON THE FILTER. HEALTH CARE PROVIDER WAS NOT 100% SURE IF THERE WAS A LEAK BUT ASKED PHARMACY TO EXCHANGE THE TUBING. SUPERVISOR 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. HEALTH CARE PROVIDER 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
    432000 INTERLINK SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER INTERNATIONAL INC. 2C7557

    Patients

    Seq Age Sex Outcome Treatment
    1 29200 DA Male