BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    43 CM (17") TRANSFER SET, PUR W/CLAVE¿, 10 UNITS

    MDR report key: 18949842 · Received March 21, 2024

    Report

    Report Number
    9617594-2024-00315
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    February 9, 2024
    Report Date
    May 29, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709123953
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED 011-H1922-10 TRANSFER SET CONNECTED TO A MULTI-FUSE EXTENSION SET AND OTHER DEVICES WERE RETURNED FOR EVALUATION. NO PHYSICAL DAMAGE OR ANOMALIES WERE OBSERVED. THE LINE AS RETURNED CONFIGURATION WAS CONNECTED TO A PRESSURE TESTER (P-1G-078) AND PRIMED AT GRAVITY PRESSURE. THERE WERE NO RESTRICTIONS IN FLOW. THE 011-H1922-10 TRANSFER SET WAS DISCONNECTED AND PRIMED INDIVIDUALLY AT GRAVITY PRESSURE AS WELL. THERE WERE NO RESTRICTIONS IN FLOW. COMPLAINT OF SET GENERATES UNSPECIFIED AIR ALARM CANNOT BE CONFIRMED OR REPLICATED. THE LOT HISTORY WAS REVIEWED, AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 43 CM (17") TRANSFER SET, PUR W/CLAVE¿, 10 UNITS WHERE IT WAS REPORTED THE INFUSION TOOK LONGER THAN THE DESIRED INFUSION TIME. DURING THE INFUSION OF PACLITAXEL, THE NURSES NOTICED DECREASED FLOW DUE TO AN "AIR OCCLUSION" ALARM WAS TRIGGERED, SIGNALING THE PRESENCES OF AIR IN THE TUBING. THE LINE WAS PRIMED TO EXPEL THE AIR AND INFUSE AT THE DESIRED FLOW RATE. THE PATIENT'S CONDITION WAS UNCHANGED BEFORE AND AFTER THE INFUSION AND NO MEDICAL INTERVENTION NEEDED. THERE WAS NO DELAY IN THERAPY, JUST AN EXTENSION OF THE INFUSION TIME, THEREFORE A LONGER CONSULTATION FOR THE PATIENT. THERE WAS AIR PRESENT IN THE TUBING, WHICH AFTERWARDS WAS REMOVED DURING PRIMING. IT IS UNKNOWN IF THE REDUCTION IN FLOW WAS LINKED TO THE AIR IN THE TUBING OR AFTER THE PUMP HAS ALARMED. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755270 43 CM (17") TRANSFER SET, PUR W/CLAVE¿, 10 UNITS STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13558622 00887709123953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALARIS ASENA GW PUMP.| PACLITAXEL, UNK MFR.