BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS CD34 REAGENT SYSTEM

    MDR report key: 5021167 · Received August 4, 2015

    Report

    Report Number
    3005290010-2015-00003
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    June 5, 2015
    Report Date
    July 8, 2015
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE: THE SEPARATION PERFORMANCE OF THE CLINIMAC CD34 REAGENT SYSTEM WAS INSUFFICIENT IN REGARD TO CELL RECOVERY. METHOD CODE: ANALYSIS OF PACS DATA. UP TO NOW THESE DATA SHEETS ARE INCOMPLETE. THEREFORE NO CLEAR EVALUATION CAN BE PERFORMED NOW.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED ABOUT LOW CD34 ANTIGEN POSITIVE STEM CELL RECOVERY OF ABOUT 47% AFTER PERFORMING THE CELL ENRICHMENT USING THE CLINIMACS CD34 REAGENT SYSTEM. 40% COULD NEITHER BE FOUND IN THE CD34 ANTIGEN NEGATIVE CELL FRACTION NOR IN THE TARGET CELL FRACTION. BASED ON THE INFORMATION PROVIDED SO FAR IT CAN BE STATED THAT THERE IS NO HARM FOR THE PATIENT BECAUSE THE PROCEDURE WENT WELL ACCORDING TO THE INFORMATION OF THE DISTRIBUTOR. (B)(6) HOSPITAL, (B)(6), CONTACT PERSON: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510649 CLINIMACS CD34 REAGENT SYSTEM CLINIMACS CD34 REAGENT SYSTEM LKN MILTENYI BIOTEC GMBH CLINIMACS CD34 REAG

    Patients

    Seq Age Sex Outcome Treatment
    1