BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS PLUS INSTRUMENT

    MDR report key: 5431271 · Received February 11, 2016

    Report

    Report Number
    3005290010-2016-00045
    Event Type
    Malfunction
    Date Received
    February 11, 2016
    Date of Event
    January 13, 2016
    Report Date
    February 11, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    UDI-DI
    04049934004636
    PMA / PMN Number
    BH110018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    I HAS REQUESTED THE PROCESS DETAILS AS WELL AS HARDCOPIES OF THE PERFORMED FLOW CYOMETRIC ALALYSIS DATA. THE CLINIMACS PLUS INSTRUMENT ITSELF WAS NOT SENT BACK TO MILTENYI FOR FURTHER INVESTIGATION. RESULTS: TWO APPLICABLE ROOT CAUSES HAVE BEEN IDENTIFIED WHICH EITHER ALONE OR IN COMBINATION DO EXPLAIN THE OBSERVED DETERIORATE PRODUCT VIABILITY AFTER THE CLINIMACS CD34 SEPARATION.

    Description of Event or Problem · 1

    THE CUSTOMER PERFORMED A LARGE SCALE CLINIMACS CD34 ENRICHMENT PROCEDURE WITH MOBILIZED APHERESIS PRODUCT CONSISTING OF 8.3X10E10 TOTAL WBCS. AFTER THE ENRICHMENT PROCESS, THE TARGET FRACTION WAS ANALYZED BY FLOW CYTOMETRY AND APPROX 38% OF THE CELLS HAD BEEN FOUND 7AAD POSITIVE, I.E. EITHER APOTOTIC OR DEAD. PROCESS CODE: 510G0O00S8O02Y0. THIS EVENT OCCURRED AT: HAMATOLOGY, ONCOLOGY & IMMUNOLOGY, BALDINGER STR. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88340 CLINIMACS PLUS INSTRUMENT CLINIMACS PLUS INSTRUMENT OVG MILTENYI BIOTEC GMBH 04049934004636

    Patients

    Seq Age Sex Outcome Treatment
    1