BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    183 CM (72") PUR SET D'INFUSIONE, PERF. CON VALVOLA, 4 ACCESSI CON BCV, CAMERA,

    MDR report key: 18328297 · Received December 14, 2023

    Report

    Report Number
    9617594-2023-01159
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    November 17, 2023
    Report Date
    December 14, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619019303
    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 WAS UNABLE TO BE RETURNED AS IT WAS CONSIDERED BIOHAZARD. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 183 CM (72") PUR SET D'INFUSIONE, PERF. CON VALVOLA, 4 ACCESSI CON BCV, CAMERA, FILTRO 15¿, RUB. CON CLAVE¿, LL GIR. THE CUSTOMER REPORTED MISMATCH OF ONE OF THE ROUTES OF THE CHEMOTHERAPY TUBING BETWEEN THE 'VAR' AND THE TUBING, CAUSING A LEAK OF THE CHEMOTHERAPY PRODUCT TO THE GROUND AND REQUIRING THE REPREPARATION OF THE BAG FOR THE PATIENT. THE EVENT WAS OBSERVED DURING USE ON A PATIENT, AT THE BEGINNING OF THE ADMINISTRATION. THERE WAS A DELAY IN THERAPY DUE TO THE NEED TO REDO THE CHEMO BAG. THE DRUG ADMINISTRATED WAS CARBOPLATIN. THE PATIENT RECEIVED THE FULL INTENDED DOSE, BUT WITH THE NEW BAG. THERE WAS NO UNDESIRABLE CLINICAL CONSEQUENCES, AND NOBODY WAS HURT AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770044 183 CM (72") PUR SET D'INFUSIONE, PERF. CON VALVOLA, 4 ACCESSI CON BCV, CAMERA, STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13611398 00840619019303

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CARBOPLATIN, MFR UNK