BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIASPAN

    MDR report key: 2511638 · Received March 26, 2012

    Report

    Report Number
    3003708554-2012-00001
    Event Type
    Other
    Date Received
    March 26, 2012
    Date of Event
    March 19, 2012
    Report Date
    March 26, 2012
    Manufacturer
    FRESENIUS KABI AUSTRIA GMBH
    Product Code
    KDL
    PMA / PMN Number
    K944866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL STERILITY TESTS ON PRIOR AND SUBSEQUENT VIASPAN BATCHES WERE INITIATED WITH RESULTS EXPECTED IN (B)(6) 2012. AT THE TIME OF REPORTING THERE HAVE BEEN NO REPORTED ADVERSE EVENTS, STABILITY OR PRODUCT STERILITY FAILURES. ADDITIONAL INFO WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2012: CASE DESCRIPTION: 510K: K944866, PRODUCT NUMBER: 333-50-1000004606, FRESENIUS (B)(4), MFR OF VIASPAN (TEVA PRODUCT NUMBER; K944866), NOTIFIED TEVA ON (B)(6) 2012 OF A MEDIA-FILL FAILURE THAT SUPPORTED THE ASEPTIC MFG FOR VIASPAN POTENTIALLY IMPACTED LOTS: 16EK0007 AND 16EK0193. FRESENIUS INITIATED A DEVIATION AND THEIR INVESTIGATION IS CONTINUING. VISUAL EXAMINATION OF THE MEDIA FILL BAGS IDENTIFIED TURBIDITY IN (B)(4) BAGS. INITIAL ANALYSIS AND INVESTIGATION APPEARS TO HAVE IDENTIFIED A SMALL LEAK IN ONE OF THE MEASUREMENT DEVICES IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASPAN SET, PERFUSION, KIDNEY, DISPOSALBE KDL FRESENIUS KABI AUSTRIA GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1