BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS CD34 REAGENT

    MDR report key: 11789241 · Received May 7, 2021

    Report

    Report Number
    3005290010-2021-00010
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 14, 2021
    Report Date
    May 7, 2021
    Manufacturer
    MILTENYI BIOTEC B.V. & CO. KG
    Product Code
    OVG
    UDI-DI
    04049934004827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT RUN, CD34 ENRICHMENT WITH TSLS. A PUMP STALL ERROR OCCURRED WITH ~8 MIN LEFT IN PROCESS. USER OPENED PUMP DOOR AND DID NOT NOTICE ANY ISSUE (IE COLLAPSED TUBING OR BLOCKAGE). FINAL RECOVERED PRODUCT WAS 22ML AND HAD LOWER THAN EXPECTED CELL NUMBERS. RUNNING THE EMERGENCY PROGRAM TWICE DID NOT RESULT IN ENOUGH CELLS FOR TREATMENT. PATIENT DID NOT RECEIVE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691254 CLINIMACS CD34 REAGENT CLINIMACS CD34 REAGENT OVG MILTENYI BIOTEC B.V. & CO. KG 70103 04049934004827

    Patients

    Seq Age Sex Outcome Treatment
    1