BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURA HEMOFILTRATION SYSTEM

    MDR report key: 1048085 · Received May 19, 2008

    Report

    Report Number
    1423500-2008-00374
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 21, 2008
    Manufacturer
    MESYS GMBH- MEDIZINISCHE SYSTEME
    Product Code
    FIR
    PMA / PMN Number
    K974652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND DETERMINED THE SCALES WERE OUT OF CALIBRATION. THE FSE CALIBRATED BOTH SCALES. MACHINE WAS TESTED ACCORDING TO THE ACCURA DATA TEST SHEET. NO OTHER PROBLEMS WERE NOTED. THE INSTRUMENT IS FULLY FUNCTIONAL. A FOLLOW UP CALL WAS PLACED TO THE FACILITY BY BAXTER CORPORATE PRODUCT SURVEILLANCE. THE BIOMED WAS ASKED IF THIS INCIDENT OCCURRED DURING PT USE. HE STATED A MEASUREMENT WAS TAKEN AFTER THE PT TREATMENT. HE ALSO STATED THAT HE DID NOT HAVE ANY DETAILS ABOUT THE INCIDENT OTHER THAN THERE WAS NO PT INJURY AND NO MEDICAL INTERVENTION. THE BIOMED WAS UNABLE TO PROVIDE FURTHER DETAILS. THE BIOMED ALSO WAS UNABLE TO IDENTIFY A CLINICAL CONTACT. NO FURTHER INFO WAS ABLE TO BE OBTAINED.

    Description of Event or Problem · 1

    A BIOMED AT THE FACILITY CALLED BAXTER TECHNICAL SERVICE REGARDING AN ACCURA HEMODIALYSIS INSTRUMENT. THE INSTRUMENT IS REMOVING TOO MUCH FLUID. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1