BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14" (36 CM) APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 BAG SPIKES, 3 CLAMPS (BLUE, 2 RE

    MDR report key: 17163245 · Received June 20, 2023

    Report

    Report Number
    9617594-2023-00251
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    May 30, 2023
    Report Date
    May 24, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619098476
    PMA / PMN Number
    K082836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COUPLE OF PHOTOS WERE SHARED BY CUSTOMER, A SMALL PLASTIC PARTICULATE FLOATING INSIDE THE DRIP SPIKE ADAPTER IS OBSERVED, THE SOURCE OF THE PARTICLE MAY COME FROM INSIDE THE DRY CHAMBER, NO ADDITIONAL DAMAGE OR ANOMALIES WERE OBSERVED IN THE PHOTOS. COMPLAINT OF PARTICULATE MATTER CAN BE CONFIRMED BASED IN THE PHOTOS RETURNED BY CUSTOMER. THE PROBABLE CAUSE OF THE EXCESS OF PLASTIC INSIDE THE DRY SPIKE ADAPTOR WAS DUE AN ERROR DURING MOLDING PROCESS FROM ENSENDA'S SUPPLIER.

    Additional Manufacturer Narrative · 0

    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. PROBABLE CAUSE OF THE DRIP CHAMBER TIP GOT BROKEN INSIDE THE DRY SPIKE ADAPTOR WAS DUE TO UNINTENTIONAL BENDING FORCE APPLIED DURING USE. CORRECTIVE ACTIONS ARE IN PROCESS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 14" (36 CM) APPX 6.9 ML, TRIFUSE ADD-ON SET WITH 3 BAG SPIKES, 3 CLAMPS (BLUE, 2 RED), DRY SPIKE ADAPTER. THE REPORTER STATED THAT AFTER NURSES PREPARE THEIR LINES BY ATTACHING THE SPIKE TO SALINE, THEN ATTACHING THE IV LINE, PLASTIC IS NOTED WITHIN IV LINE CHAMBER. WHEN UN-SPIKING THE IV LINE, PLASTIC IS SEEN IN THE SPIKE HOLE AT BASE OF THE SPIKE WITH IV LINE SPIKE INTACT. THE OTHER PRODUCTS USED WERE SEVERAL IV LINES FROM FRESENIUS KABI FK. THE EVENT WAS NOTED DURING PRIMING. NO MEDICATION WAS BEING USED WITH THE PRODUCTS. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY IN THERAPY, AND NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691782 14" (36 CM) APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 BAG SPIKES, 3 CLAMPS (BLUE, 2 RE STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6036651 00840619098476

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown IV LINES, FRESENIUS KABI.