BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS TUBING SET LS

    MDR report key: 4959956 · Received July 23, 2015

    Report

    Report Number
    3005290010-2015-00007
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    June 25, 2015
    Report Date
    July 22, 2015
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    PMA / PMN Number
    BH110018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SINCE THE CUSTOMER HAS NOT SENT THE DEFECTED CLINIMACS TUBING SET LS BACK, A ROOT CAUSE COULD NOT BE DETERMINED. ONCE THE TUBING SET LS IS RETURNED TO MILTENYI BIOTEC GMBH, A VISUAL INSPECTION WILL BE PERFORMED IN ORDER TO ANALYZE THE ROOT CAUSE. A FOLLOW-UP REPORT WILL BE WRITTEN AND SENT TO THE FDA. CONCLUSION: THIS COMPLAINT IS CLASSIFIED AS UNIDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TWO OF THEIR CLINIMACS TUBING SETS LS HAD KINKS WHEN TAKING THE TUBING SETS OUT OF THE TRANSPORT BOX. THE CUSTOMER FELT THERE WAS NO WAY LIQUID WOULD PASS THROUGH. EIGHT OTHER CLINIMACS TUBING SETS KS WERE AVAILABLE BUT NOT OPENED. THE CUSTOMER WILL KEEP THESE AND TRY TO USE THEM. NO PATIENT TREATMENT WAS DELAYED OR AFFECTED. A REPLACEMENT WAS SENT TO THE CUSTOMER. THE TUBING SETS WITH KINKS WILL BE SENT TO (B)(4) IN (B)(4) FOR FURTHER INVESTIGATION. BASED ON THE INFORMATION PROVIDED, HARM TO THE PATIENT CAN BE EXCLUDED. THE EVENT HAPPENED AT: (B)(6)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481212 CLINIMACS TUBING SET LS CLINIMACS TUBING SET LS OVG MILTENYI BIOTEC GMBH NA B2304

    Patients

    Seq Age Sex Outcome Treatment
    1