BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    84" (213 CM) 60 DROP, VENTED/NON-VENTED GRAVITY ADMIN SET W/Y SITE, 2 MICROCLAVE

    MDR report key: 19540771 · Received June 14, 2024

    Report

    Report Number
    9617594-2024-00767
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 10, 2024
    Report Date
    July 29, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709079502
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIVE (5) NEW. LIST #MRSA60-84, 84" WERE RETURNED FOR EVALUATION. AS RECEIVED NO ANOMALIES, DAMAGE OR ANOMALIES WERE OBSERVED. NO MATING DEVICE WAS RETURNED FOR EVALUATION. EACH OF THE SETS WAS PRIMED AND NO OCCLUSION OR FLOW RESTRICTION DURING PRIMING WAS CONFIRMED. THE COMPLAINT THAT THE NEEDLESS PORT VALVE DOESN'T OPEN UP CANNOT BE CONFIRMED OR REPLICATED. THE DEVICE HISTORY REVIEW (DHR) LOT#8031785 WAS REVIEWED AND NO NON-CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED CONDITION ON THE COMPLAINT. D9 - DATE RETURNED TO MFG: 7/8/2024.

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. WITHOUT THE RETURNED DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN 84" (213 CM) 60 DROP, VENTED/NON-VENTED GRAVITY ADMIN SET W/Y SITE, 2 MICROCLAVE® CLEAR, ROTATING LUER, APPROX PRIMING VOLUME: 10.8 ML GENERATED A NO-FLOW EVENT DURING USE. IT WAS REPORTED THAT THE NURSES AND ANESTHESIOLOGIST REPORTED THAT ON WEEK (B)(6) 2024, THE NEEDLESS PORT VALVE DOESN'T OPEN UP WHEN THE MEDLINE IS SCREWED IN. THEREFORE, THE MED WILL NOT INFUSE. IT HAS HAPPENED SEVERAL TIMES NOW WITH THIS BATCH. THEY ORDERED 4 CASES AND HAVE ONLY OPENED 1 BOX SO FAR. THE ANESTHESIOLOGIST DOESN'T WANT TO USE THE SAME BRAND. THE EVENT OCCURRED DURING ACTIVE PATIENT USE (DEVICE ACTIVELY CONNECTED TO THE PATIENT). THE MEDICATIONS INVOLVED WERE PROPOFOL AND REMIFENTANIL. THE RETURNING SAMPLES ARE NEW; THE USED ONES WERE DISPOSED OF. THE SAMPLE IS AVAILABLE FOR RETURN. THERE WAS NO INJURY/DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783533 84" (213 CM) 60 DROP, VENTED/NON-VENTED GRAVITY ADMIN SET W/Y SITE, 2 MICROCLAVE STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8031785 00887709079502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PROPOFOL, UNK MFR| REMIFENTANIL, UNK MFR