BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9616240-2008-00046

    MDR report key: 1150183 · Received September 4, 2008

    Report

    Report Number
    9616240-2008-00046
    Event Type
    Injury
    Date Received
    September 4, 2008
    Product Code
    FII
    PMA / PMN Number
    K001156
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A GAMBRO TECHNICAL SVC REP INSPECTED THIS PHOENIX MACHINE. THE MACHINE PERFORMED ACCORDING TO MFR'S SPECS. THE MACHINE IS BACK IN SVC WITH NO PROBLEMS. THE PT'S ALLERGY HISTORY IS UNK. FACILITY CHIEF MEDICAL DIR COULD NOT DETERMINE THE CAUSE OF THIS PT'S REACTION. THE PT WAS USING HEPARIN AND IS NOW ON A HEPARIN-FREE TREATMENT AS THE FACILITY CHIEF MEDICAL DIRECTOR SUSPECTS THAT THE HEPARIN IS AFFECTING THIS PT. BACTERIAL AND ENDOTOXIN CULTURES ON THE WATER AND DIALYSATE WERE NEGATIVE. THIS CLINIC'S DISINFECTS THEIR MACHINE WITH ACTRIL ON MONDAY, WEDNESDAY AND FRIDAYS AND WITH BLEACH AND HEAT ON TUESDAY, THURSDAY AND SATURDAYS. THE CENTRAL REVERSE OSMOSIS SYSTEM'S CARBON TANKS ARE CHECKED FOR THE ABSENCE OF CHLORINES AND CHLORAMINES PRIOR TO EACH SHIFT OF PTS. ANALYSES OF THE WATER SUPPLY WERE WITHIN NORMAL LIMITS FOR CHLORINE, CHLORAMINE, ENDOTOXIN, BACTERIA, AND TRACE ELEMENT LEVELS. THE PT DIALYZED ON A GAMBRO POLYFLUX 170H THAT IS BEING RETURNED TO HECHINGEN FOR INSPECTION. THE BTS WAS DISCARDED AND IS UNAVAILABLE FOR INSPECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1