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: 17131134 · Received June 14, 2023

    Report

    Report Number
    9617594-2023-00243
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 17, 2023
    Report Date
    March 12, 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 Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF PARTICULATE MATTER ON ITEM (B)(4) CANNOT BE CONFIRMED BY INVESTIGATION. SINCE NO EVIDENCE OF PLASTIC NOTED IN THE SPIKE HOLE AT BASE OF THE SPIKE, DUE TO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A PROBABLE CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REPORT (DHR) LOT# 6036651 WAS REVIEWED AND NO NON CONFORMITIES WERE FOUND THAT WOULD HAVE LED THE REPORTED CONDITION ON THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    SISTER SAMPLES FROM THE AFFECTED LOT NUMBER ARE AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, THEY HAVE NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 43 CM (17") APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 CLAMPS (BLUE, 2 RED), DRY SPIKE ADAPTER WHERE IT WAS REPORTED THAT AFTER THE NURSES PREPARED THEIR LINES BY ATTACHING THE CH3142 SPIKE TO SALINE, THEN ATTACHING THE IV-LINE, WHEN PRIMING SALINE, PIECES OF PLASTIC WAS NOTED WITHIN IV-LINE CHAMBER. WHEN UN-SPIKING THE IV-LINE, PLASTIC NOTED TO BE SEEN IN THE SPIKE HOLE AT BASE OF CH3142 SPIKE WITH THE IV-LINE SPIKE INTACT. THE OTHER PRODUCT USED WERE SEVERAL IV LINES WITH LIST NUMBERS: VLSP90, VLON72, VLTR42 AND VLST02 MANUFACTURED BY FRESENIUS KRABI. THERE WAS NO PATIENT INVOLVEMENT OR PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874569 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-LINE LIST #VLON72, FRESENIUS KRABI MFR.| IV-LINE LIST #VLSP90, FRESENIUS KRABI MFR.| IV-LINE LIST #VLST02, FRESENIUS KRABI MFR.| IV-LINE LIST #VLTR42, FRESENIUS KRABI MFR.| SALINE, MFR UNK.