BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS TUBING SET

    MDR report key: 5260615 · Received December 2, 2015

    Report

    Report Number
    3005290010-2015-00029
    Event Type
    Malfunction
    Date Received
    December 2, 2015
    Date of Event
    November 11, 2015
    Report Date
    December 2, 2015
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    UDI-DI
    04049934004834
    PMA / PMN Number
    BH110018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER PERFORMED A LP-14 ENRICHMENT ON THE CLINIMACS PLUS INSTRUMENT WHEN THEY ATTACHED THE PALL FILTER TO THE CLINIMACS TUBING SET THE ARM OF THE SPIKE SNAPPED OFF INSIDE THE FILTER. BASED ON THE CUSTOMERS INFORMATION, NO HARM TO THE PATIENT WAS CAUSED. THIS EVENT OCCURRED AT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790880 CLINIMACS TUBING SET CLINIMACS TUBING SET OVG MILTENYI BIOTEC GMBH B2396 04049934004834

    Patients

    Seq Age Sex Outcome Treatment
    1