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: 20058640 · Received August 24, 2024

    Report

    Report Number
    9617594-2024-01196
    Event Type
    Malfunction
    Date Received
    August 24, 2024
    Date of Event
    July 25, 2024
    Report Date
    November 11, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619082222
    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

    ALTHOUGH THE DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. WITHOUT THE RETURNED DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 0

    NO 011-CL3266 PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. A PROBABLE CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED. THE LOT NUMBER 5980905 WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN 18" (46 CM) APPX 7.8 ML, TRIFUSE ADD-ON SET W/2 CHEMOLOCK¿, 3 CLAMPS (BLUE, 2 RED), DRY SPIKE ADAPTER WAS FOUND TO HAVE PARTICULATE MATTER IN THE DRIP CHAMBER OF THE TUBING. THE REPORTER STATED THAT SHEERING OF PLASTIC OCCURRED WHEN THE CHEMOLOCK WAS SPIKED WITH A FRES-KABI LINE RESULTING IN PLASTIC PARTICLES EVIDENT IN THE DRIP CHAMBER OF LINE. IT WAS ALSO STATED THAT THERE WERE 2 INCIDENTS OF PLASTIC PARTICLES FOUND IN THE DRIP CHAMBER. THE EVENTS WERE NOTED DURING THE PRIMING OF SALINE. THE SUSPECTED PRODUCT IS AVAILABLE FOR RETRIEVAL AND EVALUATION. THE PRODUCT WAS NOT CONTAMINATED OR CONTAINED A BIOHAZARD OR CHEMOTHERAPEUTIC AGENT. THE SETS WERE NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THE DATA WAS COMMUNICATED VIA A SITE VISIT THE DAY AFTER THE EVENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246388 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. 5980905 00840619082222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown FRES KRABI VOLUMAT LINE LIST# VL ST22, LOT 8406226| NORMAL SALINE, UKN MFR