BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALOG®

    MDR report key: 14452423 · Received May 20, 2022

    Report

    Report Number
    3002879653-2022-00018
    Event Type
    Death
    Date Received
    May 20, 2022
    Date of Event
    April 20, 2022
    Report Date
    June 14, 2023
    Manufacturer
    B. BRAUN AVITUM AG
    Product Code
    KDI
    UDI-DI
    04046963686345
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT NUMBER (B)(4). 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). IT WAS REPORTED THAT A PATIENT PULLED/REMOVED THE ARTERIAL TUBING FROM THE PERMCATH (CENTRAL VENOUS CATHETER) FEED HIMSELF, THE DIALOG+ MACHINE DID NOT ALARM, AND THE PATIENT WAS TRANSFERRED TO THE ICU. UPON FURTHER INQUIRY IT WAS REPORTED THAT THE PATIENT BECAME UNRESPONSIVE AND LOOKED AS HE WAS HAVING A SEIZURE. HE WAS PLACED IN TRENDELENBURG POSITION, HIGH FLOW OXYGENATION WAS ADMINISTERED AND WAS TRANSFERRED TO THE ICU. THE CT INDICATED AN EXTENSIVE CEREBRAL VENOUS GAS LEADING TO THE DIAGNOSIS OF ACUTE EMBOLISM STROKE. AFTER THE FAMILY ELECTED TO WITHDRAW CARE, THE PATIENT EXPIRED. THE TECHNICAL INSPECTION OF THE DIALOG+ MACHINE DID NOT SHOW ANY MALFUNCTION. IT OPERATED AS INTENDED. THE DATA RECORDS OF THREE THERAPIES WERE PROVIDED FOR INVESTIGATION. THE TWO DATA RECORDS FROM 2022-04-19 SHOW TWO COMPLETE, INCONSPICUOUS TREATMENTS. AFTER A SUCCESSFULLY PASSED PREPARATION PHASE, THE DATA RECORD FROM 2022-04-20 SHOWS A SLIGHT INCREASE AND A SLIGHTLY LOWER PULSATION OF THE ARTERIAL PRESSURE 1:45 [H:MM] AFTER THERAPY START. AN ARTERIAL PRESSURE ALARM WAS NOT TRIGGERED BECAUSE THE ALARM LIMIT WAS NOT REACHED. THE COURSE AND THE BEHAVIOR OF THE ARTERIAL INDICATES THAT THE PATIENT DISCONNECTED THE ARTERIAL LINE FROM HIS CATHETER AT THAT TIME. SINCE THIS DISCONNECTION LED TO AIR ENTRY INTO THE EXTRACORPOREAL CIRCUIT, 47 SECONDS LATER THE SAD (SAFETY AIR DETECTOR) ALARMS "SAD-AIR" AND "SAD (SUP)" WERE TRIGGERED. CONSEQUENTLY, THE DIALOG+ DIALYSIS MACHINE SWITCHED INTO PATIENT-SAFE MODE (BLOOD PUMP STOP, VENOUS TUBE CLAMP SAKV CLOSED). ABOUT ONE MINUTE LATER A NEGATIVE VENOUS PRESSURE WAS DETECTED BY THE DIALYSIS MACHINE INDICATING THAT THE AIR WAS REMOVED MANUALLY BY THE OPERATOR AS DESCRIBED IN THE INSTRUCTIONS FOR USE. BECAUSE OF THIS ACTIVITY AND THE RESULTING NEGATIVE VENOUS PRESSURE, THE ALARM "VENOUS PRESSURE -LOWER LIMIT - CHECK ACCESS" WAS TRIGGERED. THIS ALARM WAS ACKNOWLEDGED BY THE OPERATOR. A FEW SECONDS LATER, THE ALARMS "SAD-AIR" AND "SAD (SUP)" WERE TRIGGERED AGAIN, INDICATING RESIDUAL AIR IN THE VENOUS LINE. THE ALARM WAS ACKNOWLEDGED BY THE OPERATOR AND THE THERAPY WAS CONTINUED UNTIL THE WARNINGS "THERAPY TIME ELAPSED" AND "UF VOLUME REACHED" INDICATED THAT THE INTENDED THERAPY TIME AND ULTRAFILTRATION VOLUME WAS REACHED. THEREAFTER, THE THERAPY WAS COMPLETED BY REINFUSING THE BLOOD IN THE EXTRACORPOREAL TO THE PATIENT. THE TECHNICAL INSPECTION AS WELL AS THE DATA RECORDS SHOW THAT THE DIALOG+ MACHINE OPERATED AS INTENDED. THERE WAS NO PRODUCT DEVIATION OR MALFUNCTION. SINCE THERE WAS NO PRODUCT DEVIATION OR MALFUNCTION, NO FURTHER ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A PATIENT PULLED/REMOVED THE ARTERIAL TUBING FROM THE PERMCATH (CENTRAL VENOUS CATHETER) FEED HIMSELF, THE DIALOG+ MACHINE DID NOT ALARM AND THE PATIENT WAS TRANSFERRED TO THE ICU. UPON FURTHER INQUIRY IT WAS REPORTED THAT THE PATIENT BECAME UNRESPONSIVE AND LOOKED AS HE WAS HAVING A SEIZURE. HE WAS PLACED IN TRENDELENBURG POSITION, HIGH FLOW OXYGENATION WAS ADMINISTERED AND WAS TRANSFERRED TO THE ICU. THE CT INDICATED AN EXTENSIVE CEREBRAL VENOUS GAS LEADING TO THE DIAGNOSIS OF ACUTE EMBOLISM STROKE. AFTER THE FAMILY ELECTED TO WITHDRAW CARE, THE PATIENT EXPIRED. THE TECHNICAL INSPECTION OF THE DIALOG+ MACHINE DID NOT SHOW ANY MALFUNCTION. IT OPERATED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964922 DIALOG® HIGH PERMEABILIT KDI B. BRAUN AVITUM AG 710200L 04046963686345

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death