BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURA HEMOFILTRATION SYSTEM

    MDR report key: 958292 · Received November 27, 2007

    Report

    Report Number
    1423500-2007-01233
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Date of Event
    October 29, 2007
    Report Date
    October 29, 2007
    Manufacturer
    MESYS
    Product Code
    FIR
    PMA / PMN Number
    K911315A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE ON SITE IN 2007 AND FOUND NO PROBLEMS. THE FSE MADE NO ADJUSTMENTS TO THE DEVICE. THE VOLTAGES, PRESSURES, PUMP DELIVERY RATES, SCALES, BLOOD LEAK DETECTOR, TEMPERATURE, AIR DETECTOR, AND VENOUS LINE CLAMP WERE TESTED AND NO PROBLEMS WERE FOUND. A SIMULATED PATIENT TREATMENT WAS DONE USING A FILTRATE COLLECTION OF 2050ML. THE ACTUAL COLLECTION WAS 2057ML, WHICH IS WITHIN ACCEPTABLE ACCURACY LIMITS. NO PROBLEMS WERE NOTED DURING THE EVALUATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING AN ACCURA DEVICE,THAT REMOVED TOO MUCH FLUID DURING A TREATMENT. THE PATIENT HAD TO BE REMOVED FROM THE DEVICE AND BE PLACED ON ANOTHER UNIT FOR THERAPY. NO PATIENT INJURY WAS REPORTED AT THE TIME OF THE INITIAL CALL. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION REGARDING THE STATUS OF THE PATIENT, BUT ALL WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURA HEMOFILTRATION SYSTEM 78FIR FIR MESYS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR