BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACS

    MDR report key: 5443654 · Received February 18, 2016

    Report

    Report Number
    5443654
    Event Type
    Malfunction
    Date Received
    February 18, 2016
    Date of Event
    November 23, 2015
    Report Date
    January 5, 2016
    Manufacturer
    MILTENYI BIOTEC INC.
    Product Code
    OVG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER CD25 ENRICHMENT OF PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC) ON A MACS MS COLUMN, ABNORMAL DEBRIS WAS SEEN WITH FLOW CYTOMETRY ANALYSIS AND MICROSCOPIC OBSERVATION. FLOW CYTOMETRY ANALYSES SHOWED AN ABNORMAL SMEAR. FURTHER INVESTIGATION SHOWED THAT THE SMEAR CONSISTED OF CD45-NEGATIVE DEBRIS. MICROSCOPIC OBSERVATION OF THE ENRICHED CELL FRACTION EXHIBITED SMALL FATTY GLOBULES. IT IS SUSPECTED THAT THE MS COLUMN IS THE SOURCE OF THE GLOBULES, ALTHOUGH IT IS NOT CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100515 MACS MAGNETIC CELL SELECTION SYSTEM FOR CD34+ CELLS FROM HPC-APHERESIS USED IN TREAT OVG MILTENYI BIOTEC INC. 5140326471

    Patients

    Seq Age Sex Outcome Treatment
    1 CLINIMACS CD25 REAGENT