BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS CD34 REAGENT

    MDR report key: 11663912 · Received April 14, 2021

    Report

    Report Number
    3005290010-2021-00008
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 14, 2021
    Manufacturer
    MILTENYI BIOTEC B.V. & CO. KG
    Product Code
    OVG
    UDI-DI
    04049934004827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED A LOW RECOVERY OF A CD34 SEPARATION. THE PATIENT COULD NOT BE TREATED WITH THIS CELLULAR PRODUCT, BUT WAS TREATED WITH AN ALTERNATIVE TREATMENT. 18% RECOVERY IN 59ML ELUTION VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560533 CLINIMACS CD34 REAGENT CLINIMACS CD34 REAGENT OVG MILTENYI BIOTEC B.V. & CO. KG 70103 6201100481 04049934004827

    Patients

    Seq Age Sex Outcome Treatment
    1