BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS® TUBING SET LS

    MDR report key: 5808561 · Received July 20, 2016

    Report

    Report Number
    3005290010-2016-00077
    Event Type
    Malfunction
    Date Received
    July 20, 2016
    Date of Event
    June 24, 2016
    Report Date
    July 19, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CLINIMACS TUBING SET LS SPIKE BROKE AT THE BUBBLE TRAP DURING USAGE. THEY INFORMED MILTENYI BIOTEC INC. REPRESENTATIVE WHICH SUPPORTED THE CUSTOMER TO CONNECT A NEW SPIKE IN A STERILE WAY, SO THAT THE CELLS COULD BE PROCESSED AS USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464440 CLINIMACS® TUBING SET LS CLINIMACS® TUBING SET LS OVG MILTENYI BIOTEC GMBH N/A B2538

    Patients

    Seq Age Sex Outcome Treatment
    1