BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18" (46 CM) APPX 7.8 ML, TRIFUSE ADD-ON SET W/2 CHEMOLOCK¿, 3 CLAMPS (BLUE, 2 RE

    MDR report key: 20182032 · Received September 10, 2024

    Report

    Report Number
    9617594-2024-01276
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    July 1, 2024
    Report Date
    October 24, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619082222
    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

    ONE USED. LIST #011-CL3266, 18" CONNECTED TO AN UNKNOWN, CHEMOLOCK AND CHEMOLOCK INJECTOR WERE RETURNED FOR EVALUATION. AS RECEIVED AN UNKNOW WHITE PARTICULATES FLOATING INSIDE THE DRIP CHAMBER WERE OBSERVED. THE PARTICULATES WERE EXTRACTED FROM INSIDE THE DRIP CHAMBER AND AN EXCESS OF PLASTIC FROM THE SAME LOCATION WAS OBSERVED. COMPLAINT OF PARTICULATE MATTER CAN BE CONFIRMED BASED IN THE PHYSICAL SAMPLES RETURNED BY CUSTOMER. NO ASSIGNABLE CAUSE RELATED TO ICU MEDICAL PRODUCT MANUFACTURING OR DESIGN WAS IDENTIFIED. REPORTED CONDITION WAS REPLICATED WHEN USING THE DRIP CHAMBER SPIKE PROVIDED BY THE CUSTOMER AND THE SHAPE OF THIS DRIP CHAMBER USED TO ACCESS THE ICU MEDICAL DRY SPIKE IS CONSIDERED THE MOST RELEVANT FACTOR TO CREATE THESE PARTICULATES. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. D9 DEVICE RETURNED TO MANUFACTURER ON 8/21/2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 18" (46 CM) APPX 7.8 ML, TRIFUSE ADD-ON SET W/2 CHEMOLOCK¿, 3 CLAMPS (BLUE, 2 RED), DRY SPIKE ADAPTER WAS FOUND TO HAVE CAUSED. IT WAS STATED THAT ¿PLASTIC PARTICLES VISIBLE IN DRIP CHAMBER ON SPIKING WITH FRES LINE¿. THE EVENT OCCURRED DURING PRIMING OF LINE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ONE WAS HARMED BY THE REPORTED EVENT. MPAHANONOT 05-SEP-2024

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223619 18" (46 CM) APPX 7.8 ML, TRIFUSE ADD-ON SET W/2 CHEMOLOCK¿, 3 CLAMPS (BLUE, 2 RE STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5980905 00840619082222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown