BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    41 CM (16") APPX 9.3 ML, QUINFUSE ADD-ON SET W/5 BAG SPIKES, 5 CLAMPS (BLUE, 4 R

    MDR report key: 21837360 · Received April 14, 2025

    Report

    Report Number
    9617594-2025-00758
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    March 18, 2025
    Report Date
    August 8, 2025
    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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED THREE (3) NEW DEVICES FOR EVALUATION. NO VISUAL DAMAGES OR ANOMALIES WERE OBSERVED. THE REPORTED COMPLAINT OF A LEAK COULD NOT BE CONFIRMED FROM THE RETURNED SAMPLES. THE RETURNED SAMPLES WERE TESTED AND MET PRODUCT SPECIFICATIONS. WITHOUT THE RETURN OF THE USED SAMPLES A PROBABLE CAUSE CANNOT BE DETERMINED. THE LOT HISTORY WAS REVIEWED, AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 41 CM (16") APPX 9.3 ML, QUINFUSE ADD-ON SET W/5 BAG SPIKES, 5 CLAMPS (BLUE, 4 RED), PLUG ADAPTER GENERATED A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT, ¿THE CONNECTION BETWEEN THE LINE AND THE QUINFUSE IS THE LOCATION OF THE LEAKING, THIS HAS OCCURRED WITH 2 OF THE QUINFUSE SETS FROM THE SAME BATCH NUMBER¿. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110044 41 CM (16") APPX 9.3 ML, QUINFUSE ADD-ON SET W/5 BAG SPIKES, 5 CLAMPS (BLUE, 4 R STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13849930

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown