BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMAFLEX SYSTEM

    MDR report key: 979254 · Received March 23, 2007

    Report

    Report Number
    2087532-2007-00069
    Event Type
    Other
    Date Received
    March 23, 2007
    Date of Event
    February 23, 2007
    Report Date
    February 23, 2007
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PRISMAFLEX WAS OBSERVED TO REMOVED 243 ML OF FLUID DURING ONE HOUR WHEN IT WAS PROGRAMMED TO REMOVE 0 ML PER HOUR. IN THE NEXT HOUR THE MACHINE REMOVED 14 ML OF FLUID WHEN PROGRAMMED TO REMOVE 0 ML PER HOUR. THE PT WAS DISCONNECTED AND HIS BLOOD WAS RETURNED AND THE TREATMENT CONTINUED ON ANOTHER PRISMAFLEX. THERE WERE NO CLINICAL CONSEQUENCES TO THE PT AS A RESULT OF THE REPORTED EVENT. THE PT IS SEPTIC AND IN RENAL FAILURE. THE PT CONTINUOUSLY RECEIVED VASOPRESSORS TO MAINTAIN HIS BLOOD PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX SYSTEM INTENSIVE CARE HEMODIALYSIS KDI GAMBRO LUNDIA AB 107493 *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other