BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS CD34 REAGENT

    MDR report key: 6060381 · Received October 27, 2016

    Report

    Report Number
    3005290010-2016-00095
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    September 23, 2016
    Report Date
    October 26, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE ANY DATA FOR A COMPREHENSIVE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER PERFORMED A CLINIMACS CD34 ENRICHMENT PROCEDURE ON THE CLINIMACS PLUS INSTRUMENT USING THE CLINIMACS TUBING SET. AFTER THE ENRICHMENT PROCEDURE, THE CUSTOMER REPORTED THAT APPROX. 40% OF THE CD34 ANTIGEN POSITIVE STEM CELLS WERE FOUND IN THE NEGATIVE FRACTION BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711296 CLINIMACS CD34 REAGENT CLINIMACS CD34 REAGENT OVG MILTENYI BIOTEC GMBH N/A 6160811005

    Patients

    Seq Age Sex Outcome Treatment
    1