BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS PLUS INSTRUMENT

    MDR report key: 6589893 · Received May 24, 2017

    Report

    Report Number
    3005290010-2017-00019
    Event Type
    Malfunction
    Date Received
    May 24, 2017
    Report Date
    May 24, 2017
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MILTENYI BIOTEC INC. INITIATED A MAINTENANCE SERVICE ON 16TH MAY 2017 WHICH INCLUDED TESTING THE PUMP UNIT MOVEMENT AND TOLERANCES. THE RESULTS WERE LAID DOV/N IN SERVICE REPORT ID #(B)(4). THERE WERE NO DEFICIENCIES FOUND AT THE TIME OF THE SERVICE. FURTHERMORE, THE CAM TEAM OF MILTENYI BIOTEC INC. ALSO NOTED THAT THEY PROVIDED THE CUSTOMER WITH AN EXTRA TUBING SET, BUFFER, REAGENT AND FROZEN CELL SAMPLE. AS A RESULT, THE CUSTOMER WAS ABLE TO RUN THE MOCK SAMPLE WITHOUT ANY ERRORS. THEREFORE, THE COMPLAINED FAILURE COULDN'T BE CONFIRMED BY MILTENYI BIOTEC.

    Description of Event or Problem · 1

    DURING ELUTION STEP OF A CLINIMACS® CD34 ENRICHMENT, THERE WAS A PUMP STALL ERROR NOTIFICATION ON THE SCREEN AND THE PRODUCT WAS NOT EXPELLED INTO THE COLLECTION BAG. THE CUSTOMER WANTED SOMEONE TO LOOK AT THE PROCESS FILE AND INVESTIGATE WHETHER THERE IS A RISK OF THIS BEING A RE-OCCURRING PROBLEM. DATE OF EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370054 CLINIMACS PLUS INSTRUMENT CLINIMACS PLUS INSTRUMENT OVG MILTENYI BIOTEC GMBH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1