BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DISPOSABLE DEVICE

    MDR report key: 19619247 · Received June 26, 2024

    Report

    Report Number
    9617594-2024-00822
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 26, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    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. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED DUE TO THE UNKNOWN LOT NUMBER.

    Description of Event or Problem · 0

    THE EVENT INVOLVED AND UNKNOWN PRODUCT WHERE THE CUSTOMER REPORTED: ¿SUDDEN DROP IN BLOOD PRESSURE IN AN UNSTABLE PATIENT (MULTIORGAN SHOCK) WITH 12MG/H OF NORADRENALINE AND V28ML/H OF DOBUTAMINE. TOILET AND MOBILIZATIONS NOT CARRIED OUT IN THE MORNING GIVEN THE SERIOUSNESS OF HIS CONDITION. AROUND 12 P.M. SUDDEN DROP IN BLOOD PRESSURE (50/30 (43)) WITHOUT MODIFICATION OF TREATMENTS, NOR CHANGE OF ELECTRIC SYRINGE PUMP, NOR MOBILIZATION. THE SENIOR OF THE UNIT WAS CALLED AND THE INTERNAL IN THE FACE OF A SURPRISING DETERIORATION WITHOUT PLAUSIBLE EXPLANATIONS. INCREASE IN AMINES WHICH HAS NO IMPACT ON THE PATIENT'S BLOOD PRESSURE. THE DOCTOR SUSPECTS A BEND IN THE TUBING WHICH WOULD EXPLAIN POOR PASSAGE OF AMINES. BY GOING UP THE TUBING, THE DISCONNECTION BETWEEN THE MANIFOLD AND THE TUBING CONNECTED TO THE PATIENT IS DISCOVERED." THE TUBING WAS RECONNECTED AND THE ADMINISTRATION OF AMINES WAS EFFECTIVE. THE PATIENT'S BLOOD PRESSURE RETURNED TO NORMAL. THERE WAS PATIENT INVOLVEMENT BUT NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595591 UNKNOWN DISPOSABLE DEVICE UNKNOWN FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 12MG/H NORADRENALINE V28ML/H DOBUTAMINE MFR UNK.| AMINES, MFR UNK.| ELECTRIC SYRINGE PUMP, MFR UNK.