BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18922719 · Received March 18, 2024

    Report

    Report Number
    9617594-2024-00278
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    January 8, 2024
    Report Date
    June 25, 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 TWO (2) USED 011-H1922-10 TRANSFER SETS CONNECTED TO A MULTI-FUSE EXTENSION SET AND OTHER DEVICES. THE FILTER VENTS ON ONE (1) OF THE USED 011-H1922-10 TRANSFER SETS WERE WETTED OUT WITH PRIOR INFUSATE. EACH OF THE LINES IN THE RETURNED CONFIGURATION WERE CONNECTED TO A FLUID SOURCE AND PRIMED AT GRAVITY PRESSURE. THE 011-H1922-10 TRANSFER SETS WERE DISCONNECTED AND PRIMED INDIVIDUALLY AT GRAVITY PRESSURE AS WELL. THERE WERE NO RESTRICTIONS IN FLOW. EACH OF THE 011-H1922-10 TRANSFER SETS WERE LEAK TESTED PER PRODUCT SPECIFICATIONS. THE SET WITH THE WETTED-OUT FILTER VENTS LEAKED FROM THE OUTLET AND INLET FILTER VENTS. THE PROBABLE CAUSE OF THE WETTED-OUT FILTER AND SUBSEQUENT LEAKAGE IS DUE TO A TEMPORARY OR COMPLETE LOSS OF HYDROPHOBIC PROPERTIES DUE TO A PRIOR INFUSATE INTERACTION. THE REPORTED COMPLAINT OF SLOW FLOW COULD NOT BE REPLICATED OR CONFIRMED ON THE TWO (2) USED 011-H1922-10 TRANSFER SETS. 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¿, (B)(4) UNITS WHERE IT WAS REPORTED THE INFUSION TIME IS HIGHER THAN THE DESIRED INFUSION TIME.¿ THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT IS DURING INFUSION. THERE WERE AT LEAST 3 INCIDENTS. THE PRODUCT WAS ADMINISTRATED IN 1 HOUR INSTEAD OF THE 30 MINUTES PLANNED. THE FILTER EXTENSION WAS CORRECTLY CONNECTED. THERE WAS NO HUMAN HARM. THE PATIENT WAS IN GOOD CONDITION BEFORE, DURING AND AFTER THE INCIDENT. NO CLINICAL CONSEQUENCE ON THE PATIENT. NO NEED FOR MEDICAL INTERVENTION. THERE WAS NO DELAY IN THERAPY, JUST AN EXTENSION OF THE INFUSION TIME, THEREFORE A LONGER CONSULTATION FOR THE PATIENT. THE BAG WAS PREPARED ON SITE. THE PLANNED DURATION FOR PEMBROLIZUMAB WAS 30 MINUTES BUT THE FINAL DURATION WAS 1 HOUR. THIS IS THE THIRD OF THREE INCIDENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211460 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