BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIX2VIAL WITH KCENTRA

    MDR report key: 13966147 · Received March 30, 2022

    Report

    Report Number
    MW5108642
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    March 26, 2022
    Report Date
    March 28, 2022
    Manufacturer
    CSL BEHRING LLC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THREE OUT OF FOUR MIX2VIAL TRANSFER SETS FAILED WHEN NURSE ATTEMPTED TO RECONSTITUTE VIALS NECESSITATING WORK AROUND TO GET VIALS RECONSTITUTED AND THEN CONTENTS WITHDRAWN. RN ENDED UP USING THE CLOSEST AVAILABLE SYRINGE - ONE FILLED WITH NSS THAT SHE SQUIRTED THE NSS OUT AND USED TO RECONSTITUTE PRODUCT OF ONE VIAL. ONE OF FIVE MIX2VIAL TRANSFER SETS FAILED TO TRANSFER DILUENT WITHIN THE LAST 60 DAYS WHEN MIXED IN THE PHARMACY FOR ANOTHER ORDER BUT WAS NOT REPORTED BECAUSE IT WAS THOUGHT TO BE A ONE-OFF EVENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872835 MIX2VIAL WITH KCENTRA SET, I.V. FLUID TRANSFER LHI CSL BEHRING LLC.
    872836 MIX2VIAL WITH KCENTRA SET, I.V. FLUID TRANSFER LHI CSL BEHRING LLC.
    872837 MIX2VIAL WITH KCENTRA SET, I.V. FLUID TRANSFER LHI CSL BEHRING LLC.
    872838 MIX2VIAL WITH KCENTRA SET, I.V. FLUID TRANSFER LHI CSL BEHRING LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female