BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS PLUS INSTRUMENT

    MDR report key: 5998045 · Received October 4, 2016

    Report

    Report Number
    3005290010-2016-00092
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 4, 2016
    Report Date
    October 4, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE AFFECTED INSTRUMENT WAS INSPECTED BY A MILTENYI BIOTEC TECHNICIAN AND NO FAILURE HAD BEEN DETECTED, THE COMPLAINED ERROR SIGNALS REMAIN UNIDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED ABOUT A WRONG BEHAVIOR OF THE CLINIMACS PLUS INSTRUMENT, S/N (B)(4), OBSERVED DURING A RUN OF THE DEPLETION 3.1 SEQUENCE ON (B)(6) 2016. PLEASE REFER TO THE CUSTOMER'S FAILURE REPORT BELOW: WHEN THEY RAN DEPLETION 3.1 TCRA/SS PROGRAM, THEY REPORTED: INSTALLATION ; OK; DATA ENTRY : OK; INTEGRITY CHECK : OK; REMOVE THE CLAMP FROM PBS/EDTA BAG; PRIMING; REMOVE THE CLAMP FROM CELL SAMPLE BAG; RUN : ISSUE IN THE SCREEN DISPLAY : THE CELL FLOW IS NOT DISPLAYED AS USUAL - ONLY THE PRIMING WASTE; BAG IS DISPLAYED. CELLS HAVE QUICKLY ENDED IN THE NON-TARGET CELL BAG. EMERGENCY STOP; CLAMP AND KIT REMOVAL; INSTRUMENT CHECK : VALVES OK; MAGNET CHECK : STRONG NOISE AND STRANGE SMELL; FINAL MESSAGE : "PLEASE FILL LIQUID SENSOR." AS A RESULT OF THESE OBSERVATIONS, THE CUSTOMER HAD TO ABORT THE PROCESS. FURTHERMORE, THE CUSTOMER STATED AT THE TIME POINT OF THE EVENT, NO PATIENT WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647931 CLINIMACS PLUS INSTRUMENT CLINIMACS PLUS INSTRUMENT OVG MILTENYI BIOTEC GMBH N/A

    Patients

    Seq Age Sex Outcome Treatment
    1