BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALOG+

    MDR report key: 11679698 · Received April 16, 2021

    Report

    Report Number
    3002879653-2021-00015
    Event Type
    Death
    Date Received
    April 16, 2021
    Date of Event
    April 6, 2021
    Report Date
    May 27, 2021
    Manufacturer
    B. BRAUN AVITUM AG - MELSUNGEN
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER: (B)(4). THE FACILITY APPROACHED B. BRAUN TO ASK FOR ASSISTANCE TO INVESTIGATE POSSIBLE CAUSES OF CONCENTRATION IRREGULARITIES IN SAMPLES. DESPITE FURTHER INQUIRIES, NEITHER ADDITIONAL INFORMATION NOR THE DATA RECORD OF THE DIALOG+ MACHINE WAS PROVIDED FOR INVESTIGATION. IT IS KNOWN THAT THE FACILITY MIXES THE ACID CONCENTRATE FOR THE DIALYSIS FLUID ON SITE. THE DIALOG+ DIALYSIS MACHINE MONITORS THE CORRECT COMPOSITION OF THE DIALYSIS FLUID BY MEASURING THE BICARBONATE AND THE FINAL CONDUCTIVITY. BOTH CONDUCTIVITY VALUES ARE CHECKED DURING THE PREPARATION PHASE. IF THERE IS A FAILURE, IT IS DETECTED BY THE DIALOG+ MACHINE AND ALARMED AND A THERAPY START IS NOT POSSIBLE. DURING THERAPY THE BICARBONATE AND THE FINAL CONDUCTIVITY ARE CONTINUOUSLY MONITORED. IF THERE IS A FAILURE, THE DIALOG+ MACHINE DETECTS IT, ALARMS AND SWITCHES INTO PATIENT-SAFE MODE (BYPASS). AS OUTLINED IN THE INSTRUCTIONS FOR USE, THE PHYSICIAN IN CHARGE IS RESPONSIBLE FOR DETERMINING THE CONCENTRATES TO BE USED. AS DESCRIBED IN CHAPTER 5.8.1 "SETTING THE DIALYSATE PARAMETERS", THE CONDUCTIVITY IS DISPLAYED ON THE SCREEN AND TOGETHER WITH OTHER THERAPY RELEVANT PARAMETERS, IT HAS TO BE CHECKED AND ACTIVELY CONFIRMED BY THE OPERATOR. FURTHERMORE, THE INSTRUCTIONS FOR USE SHOWS THE FOLLOWING WARNING IN CHAPTER 5.4 (CONNECTING THE CONCENTRATE) AND IN CHAPTER 5.8.1 (SETTING THE DIALYSATE PARAMETERS): RISK TO THE PATIENT DUE TO INCORRECT COMPOSITION OF DIALYSATE! ENSURE THAT THE CORRECT CONCENTRATES ARE PROVIDED FOR THE INTENDED THERAPY. ONLY USE CONCENTRATES WHOSE PRINTED USE-BY DATE HAS NOT EXPIRED. ONLY USE ORIGINALLY CLOSED AND INTACT CONCENTRATE CONTAINERS. OBSERVE STORAGE INFORMATION ON CONCENTRATE CONTAINERS. IT IS RECOMMENDED TO USE CONCENTRATES PRODUCED BY B. BRAUN MEDICAL INC. WHEN CONCENTRATES ARE USED THAT ARE NOT PRODUCED BY B. BRAUN MEDICAL INC. THE CORRECT MIXING RATIO AND COMPOSITION HAS TO BE CHECKED ON THE CONCENTRATE LABEL. BASED ON THE RESULTS OF THE INVESTIGATION, THE DIALOG MACHINE OPERATED AS INTENDED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER 400510461. THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: A PATIENT HAD A CARDIO PULMONARY INCIDENT DURING TREATMENT AND WAS TAKEN TO THE EMERGENCY ROOM AND EXPIRED. THE FACILITY FURTHER REPORTED THAT A SAMPLE OF THE DIALYSIS FLUID WAS TAKEN. THE POTASSIUM CONCENTRATION APPEARED TO BE HIGH. A NEW SAMPLE WAS SENT FOR RE-TESTING. THE FACILITY MIXES THE ACID CONCENTRATE FOR THE DIALYSIS FLUID ON SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574490 DIALOG+ DIALYZER, HIGH PERMEABILIT KDI B. BRAUN AVITUM AG - MELSUNGEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death