BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS

    MDR report key: 5528825 · Received March 28, 2016

    Report

    Report Number
    5528825
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    February 19, 2016
    Report Date
    March 4, 2016
    Manufacturer
    MILTENYI BIOTEC
    Product Code
    OVQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CD34 CELL SELECTION ON THE CLINIMACS INSTRUMENT, THE PROCESS ENDED BEFORE ALL OF THE PRODUCT HAD BEEN SELECTED. IT IS UNKNOWN WHY THE PROCESS STOPPED, POSSIBLY DUE TO A CLOT, AIR BUBBLE, OR DEVICE FAILURE. NO CLOTS OR AIR BUBBLES WERE OBSERVED, SO IT IS POSSIBLE THAT THERE IS AN INSTRUMENT FAILURE. MANUFACTURER RESPONSE FOR CLINIMACS INSTRUMENT, CLINIMACS (PER SITE REPORTER): THE MANUFACTURER WAS CONTACTED ABOUT THIS ISSUE. NO RESPONSE HAS BEEN RECEIVED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184461 CLINIMACS MAGNETIC CELL SELECTION SYSTEM FOR CD34+ CELLS FROM HPC-APHERESIS USED IN TREAT OVQ MILTENYI BIOTEC 151-01

    Patients

    Seq Age Sex Outcome Treatment
    1