BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX

    MDR report key: 2230502 · Received August 12, 2011

    Report

    Report Number
    8010182-2011-00008
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    PMA / PMN Number
    K080519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT HISTORY FILE REVEALED NO OTHER COMPLAINT AND NO NONCONFORMITIES HAVE BEEN REPORTED REGARDING THE INVOLVED LOT 11C0303P, WHICH CONSISTED OF 876 UNIT. THE INVOLVED FILTER SETS WERE RETURNED BY THE HOSPITAL FOR INVESTIGATION. THE INVOLVED SAMPLES WERE FILLED WITH COAGULATED BLOOD AND AN ANALYSIS COULD NOT BE DONE. THERE WERE NO DEFECTS DETECTED BY OUR VISUAL INSPECTION OF THE INVOLVED PRODUCTS.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE CONNECTION BETWEEN THE RED AND BLUE LINE ON THE FILTER WAS NOT TIGHT AND AIR WAS PULLED INTO THE CIRCUIT RESULTING IN TERMINATION OF TREATMENT AND A NEW FILTER SET. THE PT HAD AN ESTIMATED BLOOD LOSS OF 520 ML WHEN THE CONTENT OF THE FILTER SET WAS NOT RETURNED FROM TWO CONSECUTIVE FILTER SETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX PRISMAFLEX M150 SET KDI GAMBRO INDUSTRIES 11C0303P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PRISMAFLEX: (SN UNK)