BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS® TUBING SET

    MDR report key: 5229516 · Received November 17, 2015

    Report

    Report Number
    3005290010-2015-00023
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    August 6, 2015
    Report Date
    November 11, 2015
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    UDI-DI
    04049934004636
    PMA / PMN Number
    BH1100188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER PLACING THEIR CLINIMACS TUBING SET ON THEIR CLINIMACS PLUS INSTRUMENT, AND AS IT BEGAN TO PRIME, THEY NOTICED THE TUBING SET LEAKING FROM THE COLUMN. THE CELLULAR MATERIAL WAS NOT AFFECTED BECAUSE THE CELL SEPARATION WAS NOT STARTED AT THE TIME POINT OF THE EVENT, THEREFORE, NO HARM WAS CAUSED TO THE PATIENT. THE EVENT OCCURRED AT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760502 CLINIMACS® TUBING SET CLINIMACS® TUBING SET OVG MILTENYI BIOTEC GMBH N/A B2391 04049934004636

    Patients

    Seq Age Sex Outcome Treatment
    1