BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9616240-2006-00350

    MDR report key: 728493 · Received June 23, 2006

    Report

    Report Number
    9616240-2006-00350
    Event Type
    Malfunction
    Date Received
    June 23, 2006
    Product Code
    FII
    PMA / PMN Number
    k001156
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER MEDICAL INTERVENTION NOR ADDITIONAL TREATMENT WAS REQUIRED. THE PT RETURNED FOR THE NEXT REGULARLY SCHEDULED TREATMENT. IT WAS NOTED THAT THE PT CAME IN FOR DIALYSIS WITH A WEIGHT LOWER THAN POST-DIALYSIS. IN 2006, A GAMBRO TECHNICAL SERVICES FIELD REP INSPECTED THE MACHINE. HE FOUND THAT THE MACHINE WAS OPERATING WITHIN THE MFR'S SPECIFICATIONS FOR MASS BALANCE AND ULTRAFILTRATION ACCURACY. HE ALSO NOTED THAT THE CUSTOMER REPORTED THAT THEY WERE OBSERVING FLOWMETER ALARMS ON THIS MACHINE. HE PROACTIVELY REPLACED THE D1 AND D2 FLOWMETERS. THE MACHINE WAS RETURNED TO SERVICE. 510(K)# IS K001156

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1