BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    43 CM (17") APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 CLAMPS (BLUE, 2 RED), DRY SPIKE

    MDR report key: 17325370 · Received July 14, 2023

    Report

    Report Number
    9617594-2023-00384
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    June 28, 2023
    Report Date
    May 22, 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

    THE COMPLAINT INVESTIGATION WAS UPDATED AND RE-SUMMARIZED AS FOLLOWS: A USED SAMPLE #(B)(4) CONNECTED INTO A 0.9% SODIUM CHLORIDE 500ML BAG AND AN UNKNOWN, EXTENSION SET W/ DRIP CHAMBER WAS RETURNED FOR EVALUATION. AS RECEIVED, WHITE DEBRIS WAS IDENTIFIED FLOATING INSIDE THE DRY CHAMBER. FLASH WAS OBSERVED INSIDE THE DRY SPIKE ADAPTOR. THE SAMPLE WAS TESTED USING A FILTRATION SYSTEM AND PLASTIC DEBRIS WERE FOUND AFTER THE TEST. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE DRY SPIKE ADAPTOR SAMPLE #2 WAS PERFORMED ALONG WITH AN FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) STUDY OF THE PLASTIC DEBRIS FOUND DURING THE FILTRATION SYSTEM TEST FOR SAMPLE #2. THE CT SCAN SHOWED NO SIGNIFICANT INTERNAL DAMAGE. THE FTIR RESULTS SHOWED IR SPECTRUM CONSISTENCIES BETWEEN THE PLASTIC DEBRIS AND THE ADAPTOR. THE COMPLAINT OF PARTICULATE MATTER CAN BE CONFIRMED BASED IN THE PHYSICAL SAMPLE RETURNED BY CUSTOMER. NO ASSIGNABLE CAUSE RELATED TO ICU MEDICAL PRODUCT MANUFACTURING OR DESIGN WAS IDENTIFIED. THE REPORTED CONDITION WAS REPLICATED WHEN USING THE DRIP CHAMBER SPIKE PROVIDED BY THE CUSTOMER. 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 PROBABLE CAUSE OF THE DRIP CHAMBER TIP GETTING BROKEN INSIDE OF THE DRY SPIKE ADAPTOR WAS DUE TO UNINTENTIONAL BENDING FORCE APPLIED DURING USE. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. UPDATED INFORMATION CAN BE FOUND IN G1 AND H6.

    Additional Manufacturer Narrative · 0

    A USED SAMPLE #(B)(6) CONNECTED INTO A 0.9% SODIUM CHLORIDE 500ML BAG AND AN UNKNOWN, EXTENSION SET W/ DRIP CHAMBER WAS RETURNED FOR EVALUATION. AS RECEIVED IT WAS OBSERVED A WHITE DEBRIS FLOATING INSIDE THE DRY CHAMBERS. INSIDE DRY SPIKE ADAPTOR A FLASH WAS OBSERVED. THE SAMPLE WAS TESTED USING A FILTRATION SYSTEM AND PLASTIC DEBRIS WERE FOUND AFTER THE TEST. 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 MANUFACTURER¿S (ENSENADA) SUPPLIER. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. D9: DEVICE RETURNED TO MANUFACTURER ON 8-AUG-2023.

    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 43 CM (17") APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 CLAMPS (BLUE, 2 RED), DRY SPIKE ADAPTER. 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 SECOND OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185406 43 CM (17") APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 CLAMPS (BLUE, 2 RED), DRY SPIKE 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 SALINE, MFR UNK.| VLON72 IV SET, FRESENIUS KABI.| VLSP90 IV SET, FRESENIUS KABI.| VLST02 IV SET, FRESENIUS KABI.| VLTR42 IV SET, FRESENIUS KABI.