BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX

    MDR report key: 3610966 · Received February 6, 2014

    Report

    Report Number
    9616026-2013-00007
    Event Type
    Injury
    Date Received
    February 6, 2014
    Date of Event
    December 30, 2013
    Report Date
    January 10, 2014
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KDI
    PMA / PMN Number
    K110823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATA CARD FILES FROM THE PRISMAFLEX CONTROL UNIT HAVE BEEN REVIEWED. THERE IS NO INDICATION OF ANY DEVICE MALFUNCTION BASED IN THESE. THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT ANY GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PRISMAFLEX CONTROL UNIT WITH SW 7.10 INVOLVED IN THIS EVENT DOES NOT HAVE 510 (K) CLEARANCE BUT IS SIMILAR TO PRISMAFLEX CONTROL UNIT SW 5.10 (510(K) CLEARANCE K110823).

    Description of Event or Problem · 1

    A PATIENT WAS UNDERGOING A CVVH TREATMENT ON A PRISMAFLEX CONTROL UNIT FOR AN UNKNOWN REASON, THE PATIENT DISCONNECTED THE RETURN BLOOD LINE FROM THE FEMORAL CATHETER. AS A RESULT, THE PATIENT LOST AN ESTIMATED 1800 ML OF BLOOD AND MEDICAL INTERVENTION WAS REQUIRED. TWO UNITS OF PACKED RED BLOOD CELLS WERE ADMINISTERED TO THE PATIENT AT THE TIME OF THE EVENT. THE PATIENT IS REPORTED TO HAVE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77784 PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO LUNDIA AB 114870 (SW 7.10)

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening| R