BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS PLUS INSTRUMENT

    MDR report key: 6847184 · Received September 6, 2017

    Report

    Report Number
    3005290010-2017-00020
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Report Date
    September 4, 2017
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CLINIMACS CD3/CD19 DEPLETION RUNS WERE PERFORMED ON TWO DIFFERENT CLINIMACS PLUS INSTRUMENTS. THE INSTRUMENTS STOPPED MISTREAM, SAYING PROCESS ABORTED. AFTER THE CUSTOMER HAD PRESSED THE "ENTER" BUTTON, THE MACHINES PROVIDED A PROCESS CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625859 CLINIMACS PLUS INSTRUMENT CLINIMACS PLUS INSTRUMENT OVG MILTENYI BIOTEC GMBH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1