BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS TUBING SET

    MDR report key: 6061614 · Received October 27, 2016

    Report

    Report Number
    3005290010-2016-00096
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    September 23, 2016
    Report Date
    October 26, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED ON A LEAKAGE AT THE 3-WAY JUNCTION UNDERNEATH THE COLUMN ON A CLINIMACS TUBING SET. A PATIENT WAS NOT AFFECTED, THE LEAKAGE WAS DETECTED BEFORE ATTACHING THE CELL PRODUCT. THE CELLS COULD BE PROCESSED ON A NEW CLINIMACS TUBING SET. THEREFORE ANY RISK FOR THE PATIENT COULD BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712507 CLINIMACS TUBING SET CLINIMACS TUBING SET OVG MILTENYI BIOTEC GMBH N/A B2715

    Patients

    Seq Age Sex Outcome Treatment
    1