BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    41 CM (16") PUR BIFUSE CLEAR/YELLOW ADD-ON SET W/MICROCLAVE®, DRY SPIKE ADAPTER,

    MDR report key: 16336455 · Received February 9, 2023

    Report

    Report Number
    9617594-2023-00074
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    February 1, 2023
    Report Date
    February 3, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    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

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE A PROBABLE CAUSE IS UNABLE TO BE DETERMINED. THE CUSTOMER IDENTIFIED FOUR POSSIBLE LOT NUMBERS (PLOTS): 6011283 (EXPIRY DATE 06/01/2027, MFR DATE 06/01/2022). 6032905 (EXPIRY DATE 06/01/2027, MFR DATE 07/01/2022). 5989721 (EXPIRY DATE 05/01/2027, MFR DATE 07/01/2022). 5988044 (EXPIRY DATE 05/01/2027, MFR DATE 06/01/2022).

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 41 CM (16") PUR BIFUSE CLEAR/YELLOW ADD-ON SET W/MICROCLAVE®, DRY SPIKE ADAPTER, 10 UNITS. THE CUSTOMER REPORTED THAT THE TUBING TIP BROKE INSIDE THE TUBING DURING THE CONNECTION OF THE TUBING TO THE CHEMOTHERAPY TREE OF THE DEVICE. THE DEVICE CHEMOTHERAPY TREE WAS REPORTED TO BE TOO RIGID. THE BROKEN TIP WAS REMOVED FROM THE TUBING VIA KOCHER PLIERS AND THE TUBING WAS CHANGED. NO PUMP ISSUES WERE NOTED. THERE WAS A DELAY IN THERAPY OF A FEW MINUTES TO REMOVE THE BROKEN TIP WITH KOCHER PLIERS THEN CHANGE THE TUBING. THE DRUG IN USE AT THE TIME OF EVENT IS UNKNOWN. THERE WAS NO HUMAN HARM/ADVERSE EVENT, NO BLOOD LOSS, NO NEED FOR MEDICAL INTERVENTION AND NO UNPROTECTED CHEMO EXPOSURE AS A RESULT OF THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411856 41 CM (16") PUR BIFUSE CLEAR/YELLOW ADD-ON SET W/MICROCLAVE®, DRY SPIKE ADAPTER, STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown