BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMAFLEX SYSTEM

    MDR report key: 824866 · Received February 22, 2007

    Report

    Report Number
    9616026-2007-00028
    Event Type
    Other
    Date Received
    February 22, 2007
    Date of Event
    January 21, 2007
    Report Date
    January 23, 2007
    Manufacturer
    GAMBRO LUNDIA AB, MONITOR DIV.
    Product Code
    FII
    PMA / PMN Number
    k041005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATA FILES WERE REVIEWED BY THE GAMBRO FIELD SERVICE TECHNICIAN AS WELL AS TECHNICAL SUPPORT IN LUND. THERE WERE 12 OCCURRENCES OF "MALFUNCTION ALARMS" OBSERVED FROM THE DATA FILES. FROM THE REVIEW, USER ISSUES RESULTED IN A NUMBER OF THEM. THE BLOOD PUMP MALFUNCTION, FOR INSTANCE, RESULTED FROM THE NURSE SELECTING RECIRCULATION ON AN INAPPROPRIATE TIMING, AND THIS WAS ATTRIBUTED TO USER ERROR AS THE FACILITY DOES NOT HAVE A RECIRCULATION PROCEDURE. IF THE BLOOD PUMP SPEED AND THE CONTROL SYSTEM GET OUT OF SYNCHRONICITY, THIS WILL TRIGGER A GENERAL SYSTEM FAILURE. MALFUNCTION ALARM. DURING A MALFUNCTION ALARM, THE SYSTEM WILL ENTER A "SAFE STATE" BY STOPPING ALL PUMPS, CLOSING THE RETURN LINE CLAMP. TREATMENT IS SUSPENDED AND THE PATIENT'S BLOOD DOES NOT CIRCULATE THROUGH BLOOD FLOWPATH. THE PRISMAFLEX WAS CHECKED OUT OKAY AND A SIMULATION RUN DID NOT REPRODUCE THE REPORTED ALARMS. THE UNIT HAS BEEN RETURNED TO USE. THIS REPORT WILL BE TRACKED AND TRENDED WITH OTHER REPORTS OF GENERAL SYSTEM FAILURE PER THE LUND VIGILANCE REPORTING PROCEDURE.

    Description of Event or Problem · 1

    GENERAL SYSTEM FAILURE MALFUNCTION ALARM WAS REPORTED TO THE BIOMED TECHNICIAN. A SYRINGE PUMP MALFUNCTION ALARM OCCURRED AND THE MACHINE WENT SIMULTANEOUSLY INTO THE GENERAL SYSTEM FAILURE MALFUNCTION ALARM. THE NURSE TURNED OFF THE PRISMAFLEX MACHINE AND WAS ABLE TO GIVE THE BLOOD BACK MANUALLY. NO PATIENT INJURY OR BLOOD LOSS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX SYSTEM INTENSIVE CARE HEMODIALYSIS FII GAMBRO LUNDIA AB, MONITOR DIV. 6023014700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other