BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX

    MDR report key: 3567926 · Received January 10, 2014

    Report

    Report Number
    9616026-2014-00002
    Event Type
    Injury
    Date Received
    January 10, 2014
    Date of Event
    July 8, 2012
    Report Date
    December 13, 2013
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KDI
    PMA / PMN Number
    K110823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS MOST LIKELY ASSOCIATED WITH USE ERROR. THE OPERATOR REMOVED THE PRISMAFLEX SET PRIOR TO ENDING THE TREATMENT, CLAMPING THE LINES AND DISCONNECTING THE PATIENT. THIS COULD ONLY HAPPEN IF THE OPERATOR NEGLECTS THE WARNINGS ON THE PRISMAFLEX SCREEN. BEFORE THE SET IS UNLOADED, A WARNING APPEARS ON THE SCREEN STATING ALL LINES MUST BE CLAMPED BEFORE UNLOADING THE SET. THE OPERATOR IS THEN INSTRUCTED TO PRESS THE UNLOAD SOFT KEY TO CONFIRM THAT THE PATIENT IS DISCONNECTED IN ORDER TO PROCEED WITH THE UNLOADING OF THE SET. THIS WARNING IS ALSO PROVIDED IN THE PRISMAFLEX OPERATOR¿S MANUAL. THE TREATMENT DATA CARD FILES HAVE BEEN REVIEWED. THEY SHOW THAT THERE WAS A EFFLUENT SCALE ALARM IN RELATION WITH THE OPERATOR PRESSING END TREATMENT ON THE DISPLAY. THE DATA FILES ALSO SHOW THAT UNLOAD (UNLOAD OF THE FILTER SET) WAS PRESSED BY THE OPERATOR. THERE IS NO INFORMATION INDICATING THAT THE PRISMAFLEX CONTROL UNIT HAS BEEN INSPECTED BY A GAMBRO TECHNICIAN (OR ANY OTHER TECHNICIAN). THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT ANY GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PRISMAFLEX CONTROL UNIT WITH SW 5.00 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 (B)(4) DISTRIBUTOR OF RENAL PRODUCTS REPORTED THAT A PATIENT UNDERGOING CONTINUOUS RENAL REPLACEMENT THERAPY ON A PRISMAFLEX CONTROL UNIT EXPERIENCED A BLOOD LOSS WHEN THE FILTER SET WAS UNLOADED WITHOUT CLAMPING THE LINES AND DISCONNECTING THE PATIENT. THE TREATMENT WAS RECOMMENCED WITHIN 90 MINUTES AND THE PATIENT WAS REPORTED TO HAVE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19851 PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO LUNDIA AB 113874 (SW: 5.00) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening