BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9616240-2006-00340

    MDR report key: 727640 · Received June 9, 2006

    Report

    Report Number
    9616240-2006-00340
    Event Type
    Malfunction
    Date Received
    June 9, 2006
    Product Code
    FII
    PMA / PMN Number
    k001156
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INJURY OR MEDICAL INTERVENTION REQUIRED. A GAMBRO TECHNICAL SERVICES (GTS) FIELD REP INSPECTED THE MACHINE. HE FOUND A FLOW BALANCE ERROR DURING SETUP AND DURING THE SIMULATED TREATMENT. HE REPLACED AND CALIBRATED D1/D2 FLOWMETERS, CALIBRATED ALSO THE P2 PUMP, AND THE ULTRAFILTRATION BURETTE. HE PERFORMED A T1 TEST, A SETUP AND A PT SIMULATION WITHOUT ALARMS OR ERRORS. CLINICAL INVESTIGATION IS ONGOING. 510(K)# IS K001156

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1