BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIX2VIAL

    MDR report key: 8202847 · Received December 27, 2018

    Report

    Report Number
    MW5082655
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    December 26, 2018
    Report Date
    December 26, 2018
    Manufacturer
    MEDIMOP MEDICAL PROJECTS LTD. / WEST PHARMACEUTICAL SERVICES INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO MIX VIAL OF KCENTRA ACCORDING TO PACKAGE INSTRUCTIONS, THE MIX2VIAL TRANSFER SET DID NOT FUNCTION PROPERLY. THE DILUENT WAS NOT IMMEDIATELY TRANSFERRED UPON ASSEMBLY. PHARMACY STAFF WITHDREW THE DILUENT VOLUME VIA NEEDLE AND SYRINGE AND MANUALLY ADDED DILUENT TO VIAL. DEVICE MALFUNCTION LEAD TO DELAY IN THERAPY. DATES OF USE: (B)(6) 2018; DIAGNOSIS OR REASON FOR USE: LIFE THREATENING BLEEDING ANTICOAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040544 MIX2VIAL SET, I.V. FLUID TRANSFER LHI MEDIMOP MEDICAL PROJECTS LTD. / WEST PHARMACEUTICAL SERVICES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other