BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMAFLEX

    MDR report key: 1173763 · Received September 8, 2008

    Report

    Report Number
    2087532-2008-00092
    Event Type
    Other
    Date Received
    September 8, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 9, 2008
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    MQS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A FEMALE WITH CHRONIC HEMODIALYSIS PT EXPIRED 3 HRS AFTER TERMINATING CVVHDF TREATMENT ON A PRISMAFLEX MACHINE. THE PT HAD BEEN MADE A DO NOT RESUSCITATE (DNR) AT THE REQUEST OF THE FAMILY, SO HER DEATH WAS NOT UNEXPECTED. NEITHER THE PHYSICIAN NOR THE NURSES CARING FOR THE PT BELIEVE THAT A PRISMAFEX MACHINE MALFUNCTION CAUSED OR CONTRIBUTED TO THE DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other