BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS PLUS INSTRUMENT

    MDR report key: 5999824 · Received October 5, 2016

    Report

    Report Number
    3005290010-2016-00093
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 6, 2016
    Report Date
    October 4, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED PHOTOGRAPHS OF THE CLINIMACS® PLUS INSTRUMENT WITH THE CLINIMACS DEPLETION TUBING SET IN ORDER TO DEMONSTRATE THE UNUSUALLY HIGH VOLUMES OF BOTH THE TARGET CELL BAG AND THE WASTE BAG. FURTHERMORE THE PROCESS CODE (B)(64) WAS ALSO SENT TO MILTENYI BIOTEC (B)(4) FOR FURTHER INVESTIGATION AS WELL AS THE ANALYSIS OF THE CELLULAR MATERIAL PRIOR AND AFTER CELL SEPARATION. BASED ON THE DATA PROVIDED IT CAN BE STATED THAT: THE PROCESS CODE DID NOT PROVIDE ANY DEVIATIONS WITHIN THE COMPLAINED CELL PROCESSING PROCEDURE. THE PHOTOGRAPHIC INSPECTION DID ALSO NOT PROVIDE ANY IRREGULARITIES. THE INVESTIGATION OF THE ANALYSIS DATA OF THE CELLULAR MATERIAL SEPARATED DID NOT DEMONSTRATE ABNORMAL RESULTS. THEREFORE IT CAN BE ASSUMED THAT THE FAILURE RESULTED FROM A MALFUNCTION OF THE CLINIMACS® PLUS INSTRUMENT ITSELF. IT CAN BE SPECULATED THAT IT MIGHT BE A DEFECT OF A PINCH VALVE. A CONCRETE ROOT CAUSE COULDN'T BE IDENTIFIED. NO OBVIOUS DEVIATIONS WERE FOUND FROM THE DATA INSPECTION. THEREFORE, THE INSTRUMENT SERVICE OF THE DISTRIBUTOR (B)(4) IS ASKED TO SEND A SERVICE TECHNICIAN TO THE CUSTOMER TO PROVIDE THE OUTSTANDING INSTRUMENT CHECK AND TO SEND THE OUTSTANDING INFORMATION ALSO TO MILTENYI BIOTEC (B)(4), INSTRUMENT SERVICE AND COMPLAINT HANDLING DEPARTMENT.

    Description of Event or Problem · 1

    THE CUSTOMER INFORMED THEIR DISTRIBUTOR (B)(4), AS WELL AS THE MILTENYI BIOTEC HOTLINE AND COMPLAINED ABOUT UNUSUALLY HIGH VOLUMES OF BOTH THE TARGET CELL BAG AND THE WASTE BAG WITHIN A TCRA/B DEPLETION SEQUENCE USING A CLINIMACS® PLUS INSTRUMENT. THE DISTRIBUTOR (B)(4) STATED FURTHER THAT THE CUSTOMER DID CONCENTRATE THE CELLULAR MATERIAL BY CENTRIFUGATION AND THEREFORE, IT COULD BE ASSUMED INDIRECTLY THAT THE PATIENT WAS TREATED THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650446 CLINIMACS PLUS INSTRUMENT CLINIMACS PLUS INSTRUMENT OVG MILTENYI BIOTEC GMBH N/A

    Patients

    Seq Age Sex Outcome Treatment
    1