BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS TUBING SETS LS

    MDR report key: 4943561 · Received July 17, 2015

    Report

    Report Number
    3005290010-2015-00005
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 2, 2015
    Report Date
    July 16, 2015
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    PMA / PMN Number
    BH110018
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAKAGE OF THE TUBING SET WAS ONLY COMMUNICATED BY THE CUSTOMER. THERE IS NO PROOF BY PHOTOGRAPHS OR EVALUATION OF THE RETURNED PRODUCT.

    Description of Event or Problem · 1

    TUBING SET LS HAD A LEAK DURING PRIMING. IT WAS DISCOVERED DURING PRIMING PHASE OF THE SETUP AND OCCURRED AT THE CONNECTION BETWEEN PRIMING WASTE BAG AND THE TUBING SET ITSELF. ESSENTIALLY, AS SOON AS THE PRIMING WASTE ENTERED THE BAG, A TRICKLE OF BUFFER CAME DOWN FROM THE POINT. THE CELLULAR PRODUCT WAS NOT CONNECTED AND A REPLACEMENT TUBING SET WAS USED TO FINISH THE CELL SEPARATION PROCEDURE. NEITHER THE COMPLAINED TUBING SET, NOR PHOTOS OR DRAWINGS WERE AVAILABLE. IN THE MEMORANDUM FROM THE (B)(6) 2015, THE CONNECTION BETWEEN PRIMING WASTE BAG AND TUBING SET IS DESCRIBED BY THE CUSTOMER AS LEAKING. THEREFORE, THE COMPLAINT INVESTIGATION CAN ONLY BE SPECULATIVE. THE CORRESPONDING BATCH WITH L/N B2304 ((B)(4) PCS.) HAD BEEN MANUFACTURED IN OCTOBER 2014 AND WAS SOLD FROM JANUARY 2015 TO JUNE 2015. BESIDES THE ACTUAL COMPLAINT, THERE ARE NO FURTHER COMPLAINTS TO THE KNOWLEDGE OF MILTENYI BIOTEC (B)(4). THERE ARE TWO POSSIBLE REASONS FOR THE FINDING TO BE ADDRESSED: DUE TO INSUFFICIENT GLUING AND VARIATIONS IN THE EXTERNAL DIAMETER OF THE TUBING, THE CONNECTION BETWEEN THE CONNECTORS AND THE TUBING ARE NOT TIGHT ENOUGH. THEREFORE, THE LEAKAGE COULD BE OBSERVED AFTER PRESSURE TESTING. THIS COULD BE EXPLAINED BY THE INSUFFICIENT MANUFACTURING PROCESS ITSELF AND WOULD BE THEREFORE CATEGORIZED AS A PRODUCT FAILURE. HOWEVER, THE LEAK TEST AS PART OF THE RELEASE TESTING OF THE TUBING SET WAS PASSED. THEREFORE, IT IS UNLIKELY THAT A PRODUCT FAILURE WAS THE REASON FOR THE EVENT; DURING THE PREPARATION OF THE CELL SEPARATION SYSTEM USING THE TUBING SET IN QUESTION, IT MIGHT HAVE COME TO UNFORESEEN MECHANICAL STRESS WITHIN THE INSTALLATION PROCEDURE DUE TO DISPROPORTIONATE TENSILE FORCES ON THE TUBING CONNECTIONS. BASED ON THE INFORMATION PROVIDED, A HARM FOR THE PATIENT CAN BE EXCLUDED. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466734 CLINIMACS TUBING SETS LS CLINIMACS TUBING SETS LS OVG MILTENYI BIOTEC GMBH TUBING SETS LS B2304

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK