BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS PLUS INSTRUMENT

    MDR report key: 4964916 · Received August 4, 2015

    Report

    Report Number
    3005290010-2015-00004
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    June 19, 2015
    Report Date
    July 15, 2015
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    PMA / PMN Number
    BH110018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: AFTER CHECKING WITH THE MILTENYI BIOTEC INSTRUMENT SERVICE DEPARTMENT IT WAS RECOMMENDED TO REMOVE THE EPROM CARD FROM THE CLINICMACS PLUS INSTRUMENT AND TO RE-INSERT IT TO THE DEVICE. AFTER THE CUSTOMER DID THIS TWICE THE APPROACH WORKED AND THE CLINICMACS PLUS INSTRUMENT DID BOOT SUCCESSFULLY. COMPLAINT INVESTIGATION IS ATTACHED.

    Description of Event or Problem · 1

    DURING SETUP FOR A CLINICAL SEPARATION THE CLINICMACS PLUS INSTRUMENT SHOWED A "DISK ERROR" MESSAGE AFTER THE DEVICE WAS SWITCHED ON AND THUS DID NOT CONTINUE WITH THE BOOT SEQUENCE. AFTER CHECKING WITH THE MILTENYL BIOTEC INSTRUMENT SERVICE DEPARTMENT IT WAS RECOMMENDED TO REMOVE THE EPROM CARD FROM THE CLINICMACS PLUS INSTRUMENT AND TO RE-INSERT IT TO THE DEVICE. AFTER THE CUSTOMER DID THIS TWICE THE APPROACH WORKED AND THE CLINICMACS PLUS INSTRUMENT DID BOOT SUCCESSFULLY. SINCE THE CLINICMACS PLUS INSTRUMENT WAS BUILT IN 2000 AND DUE TO AGING OF THE DEVICE, THIS TYPE OF EVENT CAN BE REGARDED TO BE EXPECTED .DURING THE NEXT REGULAR MAINTENANCE OF THE DEVICE THE EPROM CARD WILL BE EXCHANGED BY THE RESPONSIBLE MILTENYI BIOTEC PERSONNEL. IT IS NO FURTHER ACTION NECESSARY. BASED ON THE INFORMATION PROVIDED THERE WAS NO HARM TO THE PATIENT AS THE INSTRUMENT WORKED PROPERLY AFTER RE-BOOTING THE SYSTEM. THE EVENT HAPPENED AT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511619 CLINIMACS PLUS INSTRUMENT CLINIMACS PLUS INSTRUMENT OVG MILTENYI BIOTEC GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA