BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15" (38 CM) APPX 4.7 ML, BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE),

    MDR report key: 17305209 · Received July 12, 2023

    Report

    Report Number
    9617594-2023-00350
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    June 1, 2023
    Report Date
    May 24, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619024918
    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

    UPDATED INVESTIGATION RECEIVED: 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. 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

    DEVICE RETURNED TO MANUFACTURER ON 8-AUG-2023. A USED SAMPLE # CH3139 CONNECTED INTO A 0.9% SODIUM CHLORIDE 500ML BAG AND AN UNKNOWN, EXTENSION SET W/ DRIP CHAMBER WAS RETURNED FOR EVALUATION. NO DEBRIS FLOATING INSIDE THE DRIP CHAMBER WAS OBSERVED. INSIDE THE DRY SPIKE ADAPTOR THE PRESENCE OF PLASTIC (FLASH) WAS OBSERVED. THE SAMPLE WAS TESTED USING A FILTRATION SYSTEM, AND IN THE FILTER A SMALL PLASTIC DEBRIS WERE FOUND BELONGING FROM THE DRY SPIKE ADAPTOR. COMPLAINT OF PARTICULATE MATTER CAN BE CONFIRMED BASED IN THE PHYSICAL SAMPLE RETURNED BY CUSTOMER. THE PROBABLE CAUSE OF THE EXCESS OF PLASTIC INSIDE THE DRY SPIKE ADAPTOR WAS DUE AN ERROR DURING MOLDING PROCESS FROM ENSENADA'S SUPPLIER. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    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 INCIDENT INVOLVED A 15" (38 CM) APPX 4.7 ML, BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE), PLUG ADAPTER ON AN UNKNOWN DATE ON (B)(6) 2023. THE REPORTER STATED THAT AFTER THE NURSES PREPARE THEIR LINES BY ATTACHING THE SPIKE TO SALINE, THEN ATTACHING THE IV LINE, PLASTIC IS NOTED IN THE IV LINE CHAMBER WHEN PRIMING WITH SALINE. THE SETS WERE NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY IN THERAPY, AND NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT. THIS IS THE FIRST OF THREE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771396 15" (38 CM) APPX 4.7 ML, BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE), STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5675428 00840619024918

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SALINE, MFR UNK| VLON72 IV SET, FRESENIUS KABI| VLSP90 IV SET, FRESENIUS KABI| VLST02 IV SET, FRESENIUS KABI| VLTR42 IV SET, FRESENIUS KABI