BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS® TUBING SET LS

    MDR report key: 5809618 · Received July 20, 2016

    Report

    Report Number
    3005290010-2016-00078
    Event Type
    Malfunction
    Date Received
    July 20, 2016
    Date of Event
    June 23, 2016
    Report Date
    July 19, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BASICALLY, THE RUN STARTED WITH "LOADING CELLS" BUT DID NOT DRAIN THE PRODUCT BAG COMPLETELY. APPROXIMATELY HALF OF THE PRODUCT WENT INTO THE COLUMN. IT DID NOT RINSE THE PALL FILTER AND THE PRODUCT BAG, BEFORE KICKING RIGHT INTO THE FIRST WASH. THE PRODUCT HAD SEVERE CLUMPING AND WAS CLOGGING UP THE FALL FILTER. THIS WAS ALSO CREATING BUBBLES IN THE DRIP CHAMBER DIRECTLY BELOW THE PALL FILTER AND THE LIQUID SENSOR. THE CUSTOMER COULD SEE IF THE BUBBLES IN THE LIQUID SENSOR TRIGGERED THE INSTRUMENT WHILE EXPECTING THAT THE ENTIRE PRODUCT WAS LOADED, BUT THAN IT SHOULD HAVE GONE DIRECTLY INTO RINSING THE FILTER AND BAG BEFORE STARTING THE FIRST WASH, BUT IT DID NOT. THE CUSTOMER CALLED THE MILTENYI BIOTEC INC. HOTLINE AND THE MILTENYI BIOTEC REPRESENTATIVE HELPED THEM TO USE ANOTHER TUBING SET TO COMPLETE THE RUN. THEREFORE ANY RISK FOR THE PATIENT COULD BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462286 CLINIMACS® TUBING SET LS CLINIMACS® TUBING SET LS OVG MILTENYI BIOTEC GMBH N/A B2304

    Patients

    Seq Age Sex Outcome Treatment
    1