BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX

    MDR report key: 3534613 · Received December 23, 2013

    Report

    Report Number
    9616026-2013-00004
    Event Type
    Injury
    Date Received
    December 23, 2013
    Date of Event
    November 30, 2013
    Report Date
    November 30, 2013
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KDI
    PMA / PMN Number
    K110823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS MOST LIKELY ASSOCIATED WITH USE ERROR. UNLOADING OF THE PRISMAFLEX SET DURING AN ONGOING TREATMENT INDICATES THE OPERATOR IGNORED 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. THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT ANY GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PRISMAFLEX CONTROL UNIT WITH SW 6.10 INVOLVED IN THIS EVENT DOES NOT HAVE 510 (K) CLEARANCE BUT IS SIMILAR TO PRISMAFLEX CONTROL UNIT SW 5.10 (510(K) CLEARANCE K110823). THERE IS NO INFORMATION INDICATING THAT THE PRISMAFLEX®CONTROL UNIT HAS BEEN INSPECTED BY A GAMBRO TECHNICIAN (OR ANY OTHER TECHNICIAN). THE TREATMENT DATA CARD FILES FROM THE PRISMAFLEX CONTROL UNIT HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    A PATIENT UNDERGOING CONTINUOUS RENAL REPLACEMENT THERAPY HAD A BLOOD LOSS WHEN THE USER UNLOADED THE FILTER SET BEFORE DISCONNECTING THE PATIENT AND CLAMPING THE LINES. GAMBRO HAS RECEIVED LIMITED INFORMATION RELATED TO THIS EVENT; THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671920 PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO LUNDIA AB 114489 (SW 6.10) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention