BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9616026-2006-00221

    MDR report key: 728459 · Received June 21, 2006

    Report

    Report Number
    9616026-2006-00221
    Event Type
    Malfunction
    Date Received
    June 21, 2006
    Product Code
    FII
    PMA / PMN Number
    k041005
    Removal / Correction Number
    GAMBRO PRISMAFLEX REBUIL
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    GAMBRO SALES REP ASSESSED THE DATA AND FOUND THAT THE FLUID DISCREPANCY WAS RELATED TO A HISTORY JUMP. A HISTORY JUMP IS RELATED TO THE OPERATOR NOT OPENING/CLOSING SCALES APPROPRIATELY. THE REP STOOD BY THE NURSE DELIVERING TREATMENT, AND FOUND THAT THE NURSE WAS NOT OPENING AND CLOSING THE SCALE WHEN CHANGING THE SOLUTION BAGS. GAMBRO'S TECHNICAL SERVICES EVALUATED THE PRISMAFLEX SYSTEM AND PERFORMED FUNCTIONALITY TEST PER MFG PROCEDURE, AND PERFORMED A SIMULATED TREATMENT. THE MACHINE PUMPS AND PRESSURE TESTED WITHIN SPECIFICATIONS. THE REPLACEMENT SCALE FAILED CALIBRATION, AND REQUIRED A NEW SCALE COMPONENT. A "SIDE-WINGS KIT," TO ENSURE THAT BAGS ARE NOT CHANGED WITHOUT FIRST OPENING THE SCALES, AS INSTRUCTED IN THE OPERATOR'S MANUAL, IS TO BE IMPLEMENTED NOT LATER THAN 10/1/2006 510(K)# IS K041005

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1