BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS PLUS INSTRUMENT

    MDR report key: 6258027 · Received January 17, 2017

    Report

    Report Number
    3005290010-2017-00103
    Event Type
    Malfunction
    Date Received
    January 17, 2017
    Date of Event
    December 20, 2016
    Report Date
    January 17, 2017
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED ON A CLINIMACS PLUS INSTRUMENT DUE TO INCOMPLETE SAMPLE LOADING CAUSED BY A PUMP STALL ERROR. THEY WERE ABLE TO FINISH THE CELL SEPARATION MANUALLY AND RESCUED THE CELLS. NO RISK FOR ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38851 CLINIMACS PLUS INSTRUMENT CLINIMACS PLUS INSTRUMENT OVG MILTENYI BIOTEC GMBH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1