BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS TUBING SET

    MDR report key: 6563533 · Received May 12, 2017

    Report

    Report Number
    3005290010-2017-00016
    Event Type
    Malfunction
    Date Received
    May 12, 2017
    Date of Event
    April 12, 2017
    Report Date
    May 12, 2017
    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 COMPLAINED ON A CLINIMACS® CD34 CELL SELECTION WHICH HAD TO BE STOPPED BECAUSE THE FLUID PATH OF THE TUBING SET USED WAS POTENTIALLY BLOCKED. ESPECIALLY THE BUBBLE TRAP COULDN'T BE FILLED. THE CUSTOMER FURTHER DESCRIBED THAT NO CLAMPS WERE ON THE MACHINE AND THAT ALL CONNECTIONS OF THE TUBING SET WERE SECURE. IN ADDITION, THE DEVICE RAN THE DAY BEFORE WITHOUT ANY PROBLEMS SO THAT A HARDWARE PROBLEM SEEMED TO BE RATHER UNLIKELY. DURING HOTLINE CALL WITH MILTENYI BIOTEC INC. THE CUSTOMER WAS FURTHER INSTRUCTED TO USE ANOTHER SPARE TUBING SET TO RESTART THE CELL SEPARATION. AS A RESULT THE SECOND PROCESS RAN FINE AND THEREFORE THE CELLULAR MATERIAL COULD BE PROCESSED. AS A RESULT, ANY RISK FOR THE PATIENT COULD BE RULED OUT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345691 CLINIMACS TUBING SET CLINIMACS TUBING SET OVG MILTENYI BIOTEC GMBH N/A B2391

    Patients

    Seq Age Sex Outcome Treatment
    1