BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC

    MDR report key: 6061498 · Received October 27, 2016

    Report

    Report Number
    3002879653-2016-00034
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 10, 2016
    Manufacturer
    B. BRAUN AVITUM AG - MELSUNGEN
    Product Code
    FKJ
    PMA / PMN Number
    K083460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015012. B. BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN AVITUM AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN AVITUM INTERNAL REPORT # (B)(4). THE MACHINE DATA LOG TREND FILES HAVE BEEN FORWARDED TO THE MANUFACTURER, AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015012. B. BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN AVITUM AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN AVITUM INTERNAL REPORT #(B)(4). EVENT 5: CUSTOMER REPORTED THAT FIVE PATIENTS SUFFERED FROM HYPERNATREMIA AFTER BEING TREATED WITH THE DIALOG+ DIALYSIS MACHINE (SN (B)(6)). ACCORDING TO THE REPORT, FOUR OF THE FIVE PATIENTS WERE HOSPITALIZED. A B. BRAUN TECHNICIAN VISITED THE FACILITY TO SERVICE THE MACHINE. ACCORDING TO HIS SERVICE REPORT, HE DETERMINED THAT THE END CONDUCTIVITY SENSOR CONTROLLER (ENDLF) AND THE CONDUCTIVITY SENSOR SUPERVISOR (ENDLF-S) VALUES MEASURED BY THE DIALOG+ MACHINE DEVIATED BY +3.2 MS/CM AND +3.6 MS/CM, RESPECTIVELY, FROM THE ACTUAL VALUE MEASURED WITH THE RESPECTIVE EXTERNAL METER. THE PERMITTED TOLERANCE IS +/- 0,2 MS/CM. THE TECHNICIAN PROCEEDED TO PROPERLY CALIBRATE THE ENDLF AND THE ENDLF-S AND THE DIALOG+ MACHINE OPERATED AGAIN AS INTENDED. ALL INFORMATION AND MACHINE TREND FILES ASSOCIATED WITH THESE EVENTS WERE FORWARDED TO THE EQUIPMENT MANUFACTURER B. BRAUN AVITUM - GERMANY. ACCORDING TO THEIR REPORT, TWO INDEPENDENT CONDUCTIVITY SENSORS CAN NOT DRIFT IN THE SAME DIRECTION IN THE SAME ORDER OF MAGNITUDE BY ITSELF. AS A RESULT, THE MANUFACTURER CONCLUDES THAT THERE MUST HAVE BEEN A FAILURE DURING THE PREVIOUS CALIBRATION OF THE SENSORS IN THE COURSE OF A TECHNICAL INTERVENTION. THE TREND DATA PROVIDED BY THE CUSTOMER WAS ANALYZED, BUT IT DID NOT GIVE ANY ADDITIONAL INFORMATION, SINCE THE RECORDED CONDUCTIVITY VALUES WERE BASED ON THE ACTUAL CALIBRATION. ACCORDING TO THE MANUFACTURER, THE CALIBRATION OF THE CONDUCTIVITY SENSORS IS DESCRIBED IN DETAIL AND COMPREHENSIVELY IN CHAPTER 4.8.3.9 OF THE SERVICE MANUAL. ONLY TRAINED PERSONNEL ARE ALLOWED TO SERVICE THE DIALOG+, (I.E. REPAIR, MAINTENANCE, SOFTWARE INSTALLATION, FIRMWARE UPDATE, RETROFITTING AND COMMISSIONING OF THE DIALOG+ MACHINE). SERVICING MUST ONLY BE PERFORMED WITH PROPER TOOLS, CALIBRATION EQUIPMENT AND BE IN ACCORDANCE WITH THE MOST RECENT REVISION OF THIS SERVICE MANUAL/TECHNICAL INFORMATION, WHICH MUST BE CLEARLY UNDERSTOOD. IN THIS SPECIFIC CASE, THE INFORMATION RELATED TO THE PROCEDURE OF THE CALIBRATION AND THE EQUIPMENT USED WAS REQUESTED, BUT IT WAS NOT PROVIDED BY THE FACILITY. A REVIEW OF CUSTOMER BIOMEDS TRAINING RECORDS SHOWS THAT THE FACILITY BIOMED WAS TRAINED BY B. BRAUN AVITUM ON THE TECHNICAL REQUIREMENTS OF THE DIALOG+ HEMODILAYSIS MACHINE. BASED ON THE RESULTS OF THIS INVESTIGATION THE MANUFACTURER CONCLUDES THAT THE PATIENTS HYPERNATREMIA WAS CAUSED BY AN INCORRECT CALIBRATION OF THE DIALOG+ DIALYSIS MACHINE. ALL INFORMATION CONCERNING THIS INCIDENT HAS BEEN INCLUDED IN OUR TREND ANALYSIS OF THE PRODUCT LINE. A HISTORICAL REVIEW OF THE CUSTOMER COMPLAINT DATABASE, REVEALED NO ADVERSE TRENDS REGARDING THIS ISSUE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: EVENT # 5: REPORTS FOUR PATIENTS WERE HOSPITALIZED FOR HIGH SODIUM LEVEL AFTER TREATMENT. UPON FURTHER FOLLOW-UP WITH THE REPORTING FACILITY, IT WAS INDICATED THAT A TOTAL OF FIVE PATIENTS WERE IMPACTED; FOUR OF THOSE PATIENTS WERE HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711373 DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC HEMODIALYSIS SYSTEM FKJ B. BRAUN AVITUM AG - MELSUNGEN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization