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: 20186792 · Received September 10, 2024

    Report

    Report Number
    9617594-2024-01282
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 15, 2024
    Report Date
    January 3, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619082222
    PMA / PMN Number
    K173477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTOGRAPH WAS PROVIDED BY THE CUSTOMER, UNABLE TO CONFIRM COMPLAINT FROM THE PHOTOGRAPH PROVIDED. RECEIVED 1) ONE (1) USED. LIST #011-CL3266, 18" (46 CM) APPX 7.8 ML, TRIFUSE ADD-ON SET W/2 CHEMOLOCK¿, 3 CLAMPS (BLUE, 2 RED), DRY SPIKE ADAPTER; LOT #6032023. ONE (1) USED. LIST #UNKNOWN, INFUSION SET; LOT #UNKNOWN. ONE (1) USED. LIST #UNKNOWN, CHEMOLOCK; LOT #UNKNOWN. ONE (1) USED. LIST #UNKNOWN, CHEMOLOCK PORT; LOT #UNKNOWN. 2) ONE (1) USED. LIST #011-CL3187, 17" (43 CM) APPX 5.4 ML, BIFUSE ADD-ON SET W/CHEMOLOCK¿, 3 CLAMPS (BLUE, 2 WHITE), DRY SPIKE ADAPTER; LOT #13979356. ONE (1) USED. LIST #UNKNOWN, INFUSION SET; LOT #UNKNOWN. ONE (1) USED. LIST #UNKNOWN, CHEMOLOCK; LOT #UNKNOWN. ONE (1) USED. LIST #UNKNOWN, CHEMOLOCK PORT; LOT #UNKNOWN. #3 AND #4) TWO (2) USED. LIST #011-CL3187, 17" (43 CM) APPX 5.4 ML, BIFUSE ADD-ON SET W/CHEMOLOCK¿, 3 CLAMPS (BLUE, 2 WHITE), DRY SPIKE ADAPTER; LOT #13970661. TWO (2) USED. LIST #UNKNOWN, INFUSION SET; LOT #UNKNOWN. TWO (2) USED. LIST #UNKNOWN, CHEMOLOCK; LOT #UNKNOWN. TWO (2) USED. LIST #UNKNOWN, CHEMOLOCK PORT; LOT #UNKNOWN. 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, UNKNOWN. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. CORRECTIVE ACTIONS ARE IN PROCESS (CAPA-0008460) D9 DEVICE RETURNED TO MANUFACTURER ON 9/13/2024.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION WAS UPDATED ON 06DEC2024 AND SUMMARIZED AS FOLLOWS: RECEIVED ONE PHOTOGRAPH; UNABLE TO CONFIRM COMPLAINT FROM THE PHOTOGRAPH PROVIDED. RECEIVED 1) ONE (1) USED. LIST #011-CL3266, 18" (46 CM) APPX 7.8 ML, TRIFUSE ADD-ON SET W/2 CHEMOLOCK¿, 3 CLAMPS (BLUE, 2 RED), DRY SPIKE ADAPTER. --> ONE (1) USED. LIST #UNKNOWN, INFUSION SET. --> ONE (1) USED. LIST #UNKNOWN, CHEMOLOCK. --> ONE (1) USED. LIST #UNKNOWN, CHEMOLOCK PORT. NO PHYSICAL DAMAGE OR OTHER ANOMALIES OBSERVED. VISUAL INSPECTION OF THE RETURN SAMPLE IDENTIFIED SMALL WHITE PARTICULATE FLOATING IN THE DRIP CHAMBER. THE CUSTOMER 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, UNKNOWN. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE COMPLAINT/EVENT INVOLVED A 18" (46 CM) APPX 7.8 ML, TRIFUSE ADD-ON SET W/2 CHEMOLOCK¿, 3 CLAMPS (BLUE, 2 RED), DRY SPIKE ADAPTER. SHEARING OF PLASTIC WAS REPORTED AFTER THE CHEMOLOCK WAS SPIKED WITH AN IV EXTENSION LINE RESULTING IN PLASTIC PARTICLES THAT WERE EVIDENT IN THE DRIP CHAMBER OF THE LINE DURING PRIMING OF SALINE. SOMEONE BECAME AWARE OF THIS ISSUE WHEN THEY OBSERVED PARTICLES IN THE DRIP CHAMBER. NO ONE WAS HARMED BY THE REPORTED EVENT. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT AND NO DELAY IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538019 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. 6032023 00840619082222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown IV LINE, LIST VL ST22, LOT 84062264, MFR FRES KABI.| SALINE SOLUTION, MFR UNK.