BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALOG+

    MDR report key: 10470853 · Received August 31, 2020

    Report

    Report Number
    3002879653-2020-00006
    Event Type
    Death
    Date Received
    August 31, 2020
    Date of Event
    August 8, 2020
    Report Date
    September 15, 2020
    Manufacturer
    B. BRAUN AVITUM AG - MELSUNGEN
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). ADDITIONAL INFORMATION WAS RECEIVED ON MEDWATCH 5096218. SECTIONS B5, E4 AND G2 HAVE BEEN UPDATED TO INCLUDE THE INFORMATION FROM THE MEDWATCH. THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS EVALUATED BY A B. BRAUN AVITUM TECHNICIAN AT THE CUSTOMER FACILITY. A TECHNICAL SAFETY INSPECTION AS WELL AS PREVENTIVE MAINTENANCE WAS PERFORMED. THE DIALOG+ MACHINE PASSED ALL TESTS AND THE MOCK TREATMENT DID NOT SHOW ANY DEVIATIONS. TWO (2) DATA RECORDS WERE PROVIDED FOR INVESTIGATION, ONE (1) FROM THE THERAPY REPORTED AND ONE (1) FROM THE THERAPY BEFORE. THE EVALUATION OF THE DATA RECORD OF THE DIALOG+ MACHINE FROM THE THERAPY BEFORE INCIDENT SHOWED A THREE (3) HOUR AND THIRTY (30) MINUTE THERAPY WITH NO ABNORMALITIES. THIS THERAPY WAS PERFORMED WITH A BICARBONATE CARTRIDGE. A BICARBONATE CANISTER WAS NOT USED. THE INVESTIGATION OF THE DATA RECORD OF THE AFFECTED THERAPY SHOWED THAT RIGHT FROM THE BEGINNING OF THE PREPARATION A CANISTER WAS USED FOR THE BICARBONATE PREPARATION INSTEAD OF A BICARBONATE CARTRIDGE AS IN THE PRIOR TREATMENT. IT CANNOT BE DETERMINED FROM THE TREND DATA IF THE USER CONNECTED A BICARBONATE CANISTER OR A CITRIC ACID CANISTER. THE CONDUCTIVITY AND THE RATIO VALUES WERE WITHIN NORMAL RANGE, THE SELF-TEST PASSED AND A THERAPY START WAS POSSIBLE. SHORTLY AFTER CONNECTING THE PATIENT THE MACHINE TRIGGERED SEVERAL BLOOD PRESSURE AND TMP ALARMS. THE MACHINE SWITCHED INTO PATIENT SAFE MODE EACH TIME. ALL OF THESE ALARMS WERE ACKNOWLEDGED BY THE USER. THE CAUSE FOR THESE ALARMS CANNOT BE DETERMINED FROM THE TREND. TWO (2) MINUTES AND SIX (6) SECONDS AFTER CONNECTING THE PATIENT, THE TREND DATA SHOWED THAT THE USER CONNECTED A BICARBONATE CARTRIDGE INTO THE BICARBONATE CARTRIDGE HOLDER AND THE MACHINE TRIGGERED THE ALARM 1054 "PREPARATION OF NEW BIC CARTRIDGE-BYPASS". AFTER ANOTHER MINUTE AND SIXTEEN (16) SECONDS (THREE (3) MINUTES AND TWENTY-TWO (22) SECONDS AFTER CONNECTING THE PATIENT) THE MACHINE TRIGGERED THE ALARM 9308 "ABPM: READING TOOK TOO LONG", BECAUSE THE MACHINE COULD NOT DETECT VALID VALUES AFTER THE MEASUREMENT WAS STARTED TWENTY-SEVEN (27) SECONDS AFTER PATIENT CONNECTION. AFTER ANOTHER MINUTE AND TWENTY-EIGHT (28) SECONDS (FOUR (4) MINUTES AND FIFTY (50) SECONDS AFTER CONNECTING THE PATIENT) THE RED DETECTOR SENSOR RDV OF THE SAFETY AIR DETECTOR (SAD) DETECTED NO BLOOD UNTIL THE TREND ENDED ABRUPTLY. THIS IS AN INDICATION THAT THE PATIENT WAS DISCONNECTED FROM THE MACHINE. THE EVALUATION OF THE DATA RECORDS OF THE DIALOG+ MACHINE DID NOT SHOW ANY DEVIATION OR MALFUNCTION. THE DIALOG+ DIALYSIS MACHINE OPERATED AS INTENDED. AS DESCRIBED ABOVE, THE THERAPY WAS PERFORMED WITH CITRIC ACID INSTEAD OF BICARBONATE. GIVEN THE FACT, THAT A SIMILAR CONDUCTIVITY CAN BE REACHED WITH CITRIC ACID AS WITH BICARBONATE AND THE MIXING RATIO IS WITHIN THE LIMIT VALUES OF THE CONDUCTIVITY, THE SELF-TEST OF THE DIALOG+ MACHINE CAN PASS AND NO ALARM WILL BE TRIGGERED DURING PREPARATION AND THE TREATMENT. THE CONDUCTIVITY MEASUREMENT OF A DIALYSIS MACHINE IS NOT SUITABLE TO DETECT CITRIC ACID INSTEAD OF BICARBONATE. DIALYSIS MACHINES IN GENERAL DO NOT MEASURE THE PH VALUE OF THE DIALYSIS FLUID. THE DIALOG+ DIALYSIS MACHINE MONITORS THE CORRECT COMPOSITION OF THE DIALYSIS FLUID BY MEASURING THE CONDUCTIVITY OF BICARBONATE AND THE FINAL CONDUCTIVITY. ALSO THE MIXING RATIO OF THE BICARBONATE AND THE ACIDIC COMPONENT IS MONITORED CONTINUOUSLY BY MONITORING THE ROTATION OF THE BICARBONATE AND THE CONCENTRATE PUMP. THIS KIND OF CONDUCTIVITY MEASUREMENT AND THE RATIO CALCULATION IS STATE OF THE ART. TO OUR KNOWLEDGE, NONE OF THE DIALYSIS MACHINES IN THE USA MARKET IS EQUIPPED WITH AN INTEGRATED CONTINUOUS PH MEASURING. IN THE IFU SECTION "PREPARING FOR HEMODIALYSIS" IN THE CHAPTER "MONITORING THE DIALYSATE" THE FOLLOWING IS REQUIRED: ANALYZE THE DIALYSATE FOR THE FOLLOWING BEFORE STARTING EACH THERAPY: PH MEASUREMENT. CONDUCTIVITY OF DIALYSATE. THE RECOMMENDED THERAPEUTIC RANGE IS PH 7.2-7.5, HCO3 # 25-38 MMOL/L. THE PH REQUIRED BY THE AAMI RD 52 STANDARD IS 6.9-7.6. IF CITRIC ACID IS USED, THE PH VALUE OF THE SAMPLE OF THE DIALYSATE IS MUCH LOWER THAN THE RECOMMENDED THERAPEUTIC RANGE. THE REQUIRED PH-TEST WOULD DETECT A MIX UP OF BICARBONATE AND CITRIC ACID. FURTHERMORE, IT IS DESCRIBED IN THE IFU TO PLACE THE DISINFECTANT CONTAINER INTO THE HOLDER AT THE REAR DOOR OF DIALYSIS MACHINE. THE TUBE OF THE BICARBONATE SUCTION ROD HAS DEFINED LENGTHS TO REDUCE THE POSSIBILITY OF CONNECTING THE SUCTION ROD TO THE CITRIC ACID CANISTER AT THE REAR DOOR. ADDITIONALLY, THE SUCTION RODS, THE CONCENTRATE CANISTERS, THE BICARBONATE CANISTERS AND THE DISINFECTANT CITRIC ACID CANISTERS ARE COLOR-CODED. THE BICARBONATE AND THE BICARBONATE SUCTION ROD ARE BLUE CODED AND THE DISINFECTANT CANISTER IS YELLOW CODED. THESE DIFFERENT COLORS (BLUE OF THE BICARBONATE AND YELLOW OF THE DISINFECTANT) SUPPORT THE USER TO AVOID ANY MIX UP. BOTH THE TECHNICAL SAFETY INSPECTION OF THE DIALOG+ MACHINE ON-SITE AND THE ANALYSIS OF THE DATA RECORDS CONFIRM THERE WAS NO DEVICE MALFUNCTION. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: A FATALITY OCCURRED DURING A PATIENT THERAPY. THE CALLER STATED THAT THE BELIEF IS THIS WAS NOT A MACHINE ISSUE BUT A WORK FLOW ISSUE. THE CALLER STATED HE WAS INFORMED NOT TO PROVIDE ANY DETAILS. ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH 5096218. PER THE INFORMATION ON THE MEDWATCH: CITRIC ACID USED IN PLACE OF BICARBONATE. B. BRAUN DIALOG DIALYSIS MACHINE SW 9.1X DOES NOT HAVE BUILT IN PH METER AND ALLOWED USER TO CONTINUE ADMINISTERING DIALYSIS WITHOUT CHECKING PH.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: A FATALITY OCCURRED DURING A PATIENT THERAPY. THE CALLER STATED THAT THE BELIEF IS THIS WAS NOT A MACHING ISSUE BUT A WORK FLOW ISSUE. THE CALLER STATED HE WAS INFORMED NOT TO PROVIDE ANY DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938400 DIALOG+ DIALYZER, HIGH PERMEABILIT KDI B. BRAUN AVITUM AG - MELSUNGEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other