BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMAFLEX

    MDR report key: 710276 · Received May 2, 2006

    Report

    Report Number
    710276
    Event Type
    Other
    Date Received
    May 2, 2006
    Date of Event
    April 25, 2006
    Report Date
    May 1, 2006
    Manufacturer
    GAMBRO RENAL PRODUCTS, INC.
    Product Code
    KPF
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    IT APPEARS THAT THE PATIENT RECEIVED A LARGE BOLUS OF HEPARIN. THE MACHINE HISTORY SHOWS THAT THE SET WAS CHANGED FOUR TIMES IN TWENTY-TWO HOURS. ON THE FOURTH SET CHANGE THE MACHINE DID NOT RESPOND TO THE END TREATMENT INSTRUCTION WITH A CORRESPONDING TREATMENT COMPLETE RESPONSE. EACH OF THE OTHER END TREATMENT INSTRUCTIONS, BOTH ON THIS PATIENT AND IN OUR TESTS HAD A CORRESPONDING TREATMENT COMPLETE RESPONSE. THE PATIENT'S PARTIAL THROMBOPLASTIN TIME READINGS WERE 211 SECONDS AFTER THIS EVENT, AND THEY WERE APPROXIMATELY 30 SECONDS TWENTY-FOUR HOURS EARLIER. THERE IS AN INDICATION THAT THE PATIENT ACTUALLY GOT THE EXTRA HEPARIN. THE PATIENT HAD NO ADVERSE RESPONSE TO THE EXTRA MEDICATION. THE MACHINE HAD MANY SYRINGE PUMP ALARMS TOWARDS THE END OF TREATMENT. IN OUR TESTS WE WERE UNABLE TO SILENCE THE SYRINGE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX CVVH KPF GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR