BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS TUBING SET LS

    MDR report key: 6087372 · Received November 8, 2016

    Report

    Report Number
    3005290010-2016-00097
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A LEAKAGE AT THE BUBBLE TRAP OF ONE CLINLMACSSI TUBLNG SET LS. THEY OBSERVED THE LEAKAGE AT THE BEGINNING OF THE CELL SEPARATION RUN. THE CUSTOMER FURTHERMORE POINTED OUT THAT THEY COULD RESCUE THE CELLS. AS A CONSEQUENCE, THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737359 CLINIMACS TUBING SET LS CLINIMACS TUBING SET LS OVG MILTENYI BIOTEC GMBH N/A B2714

    Patients

    Seq Age Sex Outcome Treatment
    1