BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16" (41 CM) APPX 6.3 ML, TRIFUSE ADD-ON SET W/2 SPIROS®, BAG SPIKE, 3 CLAMPS (BL

    MDR report key: 16811987 · Received April 25, 2023

    Report

    Report Number
    9617594-2023-00152
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    March 27, 2023
    Report Date
    March 30, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    UDI-DI
    00840619025687
    PMA / PMN Number
    K173477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 16" (41 CM) APPX 6.3 ML, TRIFUSE ADD-ON SET W/2 SPIROS¿, BAG SPIKE, 3 CLAMPS (BLUE, 2 RED), DRY SPIKE ADAPTER WHERE IT WAS REPORTED THAT THE RUBBER SCRAPS FELL INTO THE TUBE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT/PATIENT HARM, AND NO DELAY IN CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865650 16" (41 CM) APPX 6.3 ML, TRIFUSE ADD-ON SET W/2 SPIROS®, BAG SPIKE, 3 CLAMPS (BL CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CH3227 5208897 00840619025687

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown