BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    42 CM (17") APPX 2.8 ML, PUR EXT SET WITH BAG SPIKE W/ INTEGRATED CLAVE®, BCV AN

    MDR report key: 9611887 · Received January 21, 2020

    Report

    Report Number
    9617594-2020-00018
    Event Type
    Malfunction
    Date Received
    January 21, 2020
    Date of Event
    December 24, 2019
    Report Date
    December 31, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619019020
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED. NO PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY REVIEW FOR LOT NUMBER 4110831 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A PROBABLE CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A 42 CM (17¿) PUR EXT SET WITH BAG SPIKE W/INTEGRATED CLAVE, BCV AND CAP WITH FILTER WHERE THE TUBING HAS COME LOOSE FROM SPIKE WITH THE CLAVE WHICH CAUSED LEAKAGE WITH POTENTIALLY TOXIC PRODUCT. THE SOLUTION BEING USED WAS CARBOPLATIN AND THE LEAKING OCCURRED AT THE BEGINNING OF THE INFUSION. THE CHEMO DID NOT COME IN CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER. A SPILL KIT WAS USED, AND THE CHEMO WAS CLEANED UP PER PROTOCOL. THE SET WAS DESTROYED IN THE NURSING WARD DUE TO LEAKAGE WITH A CYTOSTATIC AGENT. THERE WAS PATIENT INVOLVEMENT AND A DELAY IN CRITICAL THERAPY BUT NO ADVERSE EVENT NOR NEED FOR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75562 42 CM (17") APPX 2.8 ML, PUR EXT SET WITH BAG SPIKE W/ INTEGRATED CLAVE®, BCV AN STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4110831 00840619019020

    Patients

    Seq Age Sex Outcome Treatment
    1