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: 17325610 · Received July 14, 2023

    Report

    Report Number
    9617594-2023-00387
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    June 28, 2023
    Report Date
    June 30, 2023
    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 DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF PARTICULATE MATTER ON ITEM 011-CH3142 COULD NOT BE CONFIRMED BY INVESTIGATION SINCE NO 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 FOR LOT#8688075 WAS REVIEWED AND NO NON CONFORMITIES WERE FOUND THAT WOULD HAVE LED THE REPORTED COMPLAINT.

    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 THREE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654667 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. 8688075 00840619098476

    Patients

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