BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9616026-2007-00100

    MDR report key: 954120 · Received October 26, 2007

    Report

    Report Number
    9616026-2007-00100
    Event Type
    Malfunction
    Date Received
    October 26, 2007
    Product Code
    MQS
    PMA / PMN Number
    K041005
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT HAS BEEN CLASSIFIED AS A FLOW RATE DISCREPANCY. THE TREATMENT DATE FILES ARE NOT AVAILABLE. GAMBRO LUNDIA AB HAS DEVELOPED A PROCEDURE TO ADDRESS POTENTIAL FLOW RATE DISCREPANCIES, AS DESCRIBED IN THE ADVISORY NOTICE. THIS PROCEDURE HAS BEEN DISTRIBUTED TO ALL USERS OF PRISMAFLEX DEVICES. SOFTWARE CHANGES HAVE ALSO BEEN DEVELOPED, WHICH WILL BE IMPLEMENTED IN A FUTURE SOFTWARE REVISION. THE GAMBRO TECH THAT INVESTIGATED THE PRISMALFLEX MACHINE CONFIRMED THAT THE INSTRUCTIONS IN THE ADVISORY NOTICE 019 (WHICH HAD BEEN PROVIDED TO THE CLINIC) HAD NOT BEEN FOLLOWED. THE TECH EXPLAINED THE PROCEDURES TO THE CLINIC STAFF AND SHOWED THEM WHAT THEY NEED TO DO TO RESOLVE A DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MQS

    Patients

    Seq Age Sex Outcome Treatment
    1