BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS CD34 REAGENT

    MDR report key: 5635406 · Received May 5, 2016

    Report

    Report Number
    3005290010-2016-00066
    Event Type
    Malfunction
    Date Received
    May 5, 2016
    Date of Event
    March 24, 2016
    Report Date
    May 4, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    UDI-DI
    04049934004827
    PMA / PMN Number
    BH110018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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© SEPARATION. MOREOVER, FLOW CYTOMETRY DATA HAS BEEN REQUESTED. THE CUSTOMER SENT IN A FILLED INVESTIGATION QUESTIONNAIRE AND A FLOW CYTOMETRY ANALYSIS SHEET FROM THE TARGET FRACTION. BASED ON THE GIVEN INFORMATION FOLLOWING STATEMENT CAN BE MADE: THE SOURCE PRODUCT FOR THE SELECTION PROCEDURA WAS A FRESH, MOBILIZED LEUKAPHERESIS PRODUCT, CONTAINING 35XL0E9 TNC (TOTAL NUCLEATED CELLS) AND 364.8XL0E6 CD34 +-CELLS (= 1.04% CD34+). THE SEPARATION WAS PERFORMED WITH ONE VIAL OF CLINIMACS® CD34 REAGENT, AND THE RESPECTIVE CLINIMACS® TUBING SET. THE REAGENT WAS USED WITHIN THE SPECIFICATION USING THE ENRICHMENT PROGRAM CD34 SELECTION 1. THE PROCESS CODE DOES NOT INDICATE ANY MALFUNCTION OF THE CLINIMACS® PLUS INSTRUMENT. IGG WAS ADDED PRIOR LABELING FOR BLOCKING OF UNSPECIFIC BINDING SITES. ONLY 12.1X106 OUT THE INITIAL 365X106 CD34-T- CELLS WERE FOUND IN THE TARGET CELL BAG. THE RESULTING TARGET CELL RECOVERY IS THEREFORE 3.3%. NO FLOW CYTOMETRY DATA AVAILABLE FOR NEGATIVE FRACTION AND/OR INITIAL CELL PRODUCT. THE FLOW ANALYSIS DATA SHEET FROM THE TARGET CELL FRACTION DOES NOT INDICATE ANY DISCREPANCIES IN THE GATING. THE PURITY FOR CD34+ STEM CELLS WAS 88.4%. SMALL AGGREGATES WERE OBSERVED IN THE ORIGINAL FRACTION. BASED ON THE DATA PROVIDED BY THE CUSTOMER IT IS IMPOSSIBLE TO MAKE ANY ASSESSMENT REGARDING THE POSSIBLE ROOT CAUSE. THE REAGENT WAS USED WITHIN THE SPECIFICATION. NO MAJOR DEVIATIONS FROM THE RECOMMENDED PROTOCOL HAVE BEEN IDENTIFIED. NO MALFUNCTION OF THE CLINIMACS® PLUS INSTRUMENT HAS BEEN IDENTIFIED BY THE PROCESS CODE. BUT, IT COULD NOT BE RULED OUT WHETHER LOW RECOVERY WAS CAUSED BY: UNFAVORABLE COMPOSITION OF THE INITIAL CELL PRODUCT (CELL AGGREGATES WERE OBSERVED).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289094 CLINIMACS CD34 REAGENT CLINIMACS CD34 REAGENT OVG MILTENYI BIOTEC GMBH N/A 6151218004 04049934004827

    Patients

    Seq Age Sex Outcome Treatment
    1