BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS CD34 REAGENT

    MDR report key: 5634846 · Received May 5, 2016

    Report

    Report Number
    3005290010-2016-00065
    Event Type
    Malfunction
    Date Received
    May 5, 2016
    Date of Event
    March 11, 2016
    Report Date
    May 4, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    UDI-DI
    04049934004827
    PMA / PMN Number
    BK090020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MILTENYI BIOTEC (B)(4) HAS HANDED OVER AN INVESTIGATION QUESTIONNAIRE TO THE CUSTOMER TO OBTAIN MORE DETAILS ABOUT THE COMPLAINED CLINIMACS® CELL SEPARATION. BASED ON THE ENTIRE DATA AND THE FACS PLOTS OF THE POSITIVE FRACTION RECEIVED, FOLLOWING RESULTS CAN BE ASCERTAINED: THE SOURCE PRODUCT FOR THE SELECTION PROCEDURE WAS A FRESH, MOBILIZED LEUKAPHERESIS PRODUCT CONTAINING 27XL0E9 TNC AND 76,8XL0E6 CD34-CELLS (= 0,28% CD34+). THE SEPARATION WAS PERFORMED WITH ONE VIAL OF CLINIMACS® CD34 REAGENT, CLINIMACS® TUBING SET AND CD34 SELECTION!-PROGRAM. IGG WAS ADDED PRIOR LABELING FOR BLOCKING OF UNSPECIFIC BINDING SITES. SMALL AGGREGATES WERE OBSERVED IN THE ORIGINAL FRACTION POSITIVE FRACTION: VIABILITY WAS 94% CD34+ RECOVERY WAS INDEED 31 % PURITY WAS 94% RESULTS #: THE SELECTION PROCEDURE HAS BEEN PERFORMED INSIDE THE SPECIFICATIONS OF THE CLINIMACS® CD34 REAGENT AND THE RESPECTIVE TUBING SET. THE PLT-WASH WAS NOT EXACTLY DONE AT A 1:3 DILUTION. BY USING A LOWER AMOUNT OF BUFFER, THE PLATELET REMOVAL MIGHT NOT HAVE BEEN SUFFICIENT WITH POTENTIAL CONSEQUENCE OF WEAK LABELING AND LOSS OF CD34+-CELLS.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT THE RECOVERY OF CD34+-CELLS WAS LOW (3.3%) FOR A CLINIMACS SEPARATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289157 CLINIMACS CD34 REAGENT CLINIMACS CD34 REAGENT OVG MILTENYI BIOTEC GMBH N/A 6151218004 04049934004827

    Patients

    Seq Age Sex Outcome Treatment
    1