BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALOG A + HE/BIC

    MDR report key: 6001084 · Received October 5, 2016

    Report

    Report Number
    3002879653-2016-00029
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 23, 2016
    Manufacturer
    B. BRAUN AVITUM AG - MELSUNGEN
    Product Code
    FKJ
    PMA / PMN Number
    K083460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 TREND FILES HAVE BEEN REQUESTED FROM THE FACILITY, 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 AVIUM INTERNAL REPORT (B)(4). INITIALLY, IT WAS REPORTED THAT DURING A THERAPY, THE DIALOG+ DIALYSIS MACHINE WAS SET TO 600 ML ULTRAFILTRATION. AFTER A POWER OUTAGE, THE MACHINE RESUMED THE THERAPY. WHEN THE PATIENT COMPLAINED ABOUT CRAMPING THE NURSE CHECKED THE MACHINE AND NOTICED THAT THE ULTRAFILTRATION WAS SET TO 1600 ML. THE PATIENT WAS INFUSED WITH 500 ML SALINE AND WENT HOME ON HER OWN. ACCORDING TO THE SAME REPORT, THREE THERAPIES WERE RUN BY THE FACILITY'S BIOMED AFTER THE INCIDENT, WITHOUT ANY ISSUES. THE DIALYSIS MACHINE OPERATED AS INTENDED. AFTER A FOLLOW UP CALL WITH THE FACILITY, THE CUSTOMER REPORTED THE FOLLOWING INFORMATION: - PRESCRIBED WEIGHT TO BE REMOVED: 0.6 KG - PATIENT WEIGHT BEFORE THE TREATMENT: 88.3 - PATIENT WEIGHT AFTER TREATMENT: 86.6 - BLOOD PRESSURE, PRE, DURING AND POST THERAPY: 140/71, 103/47, 114/45 AFTER A SECOND FOLLOW UP WITH THE BIOMED, HE REPORTED THAT THE INITIAL INFORMATION WAS INCORRECT. THE ULTRAFILTRATION ON THE MACHINE WAS SET AT 1200 ML AND NOT 600 ML, AS ORIGINALLY REPORTED. HE ALSO STATED THAT THE SETTING DID NOT CHANGE AFTER THE POWER FAILED AND THE MACHINE CAME BACK ON. THE ULTRAFILTRATION SETTING REMAINED AT 1200 ML AND NOT 1600 ML AS ORIGINALLY REPORTED. ALL INFORMATION ASSOCIATED WITH THIS EVENT WAS FORWARDED TO THE EQUIPMENT MANUFACTURER B. BRAUN AVITUM - GERMANY. SEVERAL ATTEMPTS WERE MADE TO OBTAIN THE MACHINE TREND FILES FOR THAT SPECIFIC THERAPY, BUT THE FACILITY DID NOT SUBMIT THE FILES FOR EVALUATION. AFTER A REVIEW OF THE INFORMATION RECEIVED, THE MANUFACTURER CONCLUDES THAT, BASED ON THE FACT THAT THREE THERAPIES WERE RUN WITHOUT ANY ISSUES AND THE ULTRAFILTRATION SETTING REMAINED UNCHANGED AFTER THE POWER OUTAGE, THE DIALOG+ DIALYSIS MACHINE DID NOT EXPERIENCE A MALFUNCTION AND OPERATED AS INTENDED. THE MANUFACTURER FURTHER REPORTS THAT A DEVIATION FROM THE ULTRAFILTRATION GOAL CAN ALSO BE CAUSED BY OTHER FACTORS, WHICH MIGHT NOT BE RELATED TO THE MACHINE. SOME OF THESE FACTORS INCLUDE; THE WEIGHING PROCEDURE AND/OR FOOD AND DRINK INTAKE DURING DIALYSIS. 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: REPORTS THE MACHINE WAS SET FOR 0.6K UF REMOVAL. A POWER OUTAGE OCCURRED. WHEN THE MACHINE CAME BACK ON, THE TREATMENT CONTINUED UNTIL THE PATIENT COMPLAINED OF CRAMPING. THE NURSE CHECKED THE MACHINE AND IT WAS SET AT 1.6K. THERE WERE NO PUMP ALARMS. THE PATIENT OVER FILTRATED. A BOLUS OF 500ML SALINE WAS GIVEN FOR THE CRAMPS. THE PATIENT WENT HOME ON HER OWN. THE MACHINE HAS SINCE BEEN USED ON AT LEAST 2 OR 3 OTHER TREATMENTS WITHOUT ANY ISSUES. ADDITIONAL PATIENT INFO: PRESCRIBED WEIGHT TO BE REMOVED - 0.6 PATIENT WEIGHT BEFORE THE TREATMENT AND AFTER - PRE WEIGHT: 88.3 / POST WEIGHT: 86.6 BLOOD PRESSURE PRE, DURING, AND POST THERAPY - 140/71; 103/47; 114/45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650796 DIALOG A + HE/BIC HEMODIALYSIS SYSTEM FKJ B. BRAUN AVITUM AG - MELSUNGEN

    Patients

    Seq Age Sex Outcome Treatment
    1