BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALOG+

    MDR report key: 11968052 · Received June 9, 2021

    Report

    Report Number
    3002879653-2021-00025
    Event Type
    Death
    Date Received
    June 9, 2021
    Date of Event
    April 16, 2021
    Report Date
    July 15, 2021
    Manufacturer
    B. BRAUN AVITUM AG - MELSUNGEN
    Product Code
    KDI
    UDI-DI
    04046964285608
    PMA / PMN Number
    K083460
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 DIALOG+ DIALYSIS MACHINE WAS TECHNICALLY INSPECTED BY THE CUSTOMER'S TECHNICIAN AFTER THE DESCRIBED EVENT. IT WAS CONFIRMED THAT IT OPERATED AS INTENDED AND HAS BEEN CLEARED FOR USE BY THE CUSTOMER. DEPENDENT ON THE PRESSURE DROP AND THE ALARM LIMITS SET, THE PRESSURE MONITORING SYSTEM OF A DIALYSIS MACHINE DOES NOT RELIABLY DETECT A DISCONNECTION OR DISLODGEMENT OF THE VENOUS PATIENT ACCESS. THEREFORE, THE INSTRUCTIONS FOR USE OF THE DIALOG+ DIALYSIS MACHINE SHOWS THE FOLLOWING WARNING: RISK TO PATIENT DUE TO BLOOD LOSS IF CANNULAS GET DISCONNECTED OR DISLODGED! STANDARD MONITORING FUNCTION OF THE DIALYSIS MACHINE CANNOT ENSURE DETECTION IF THE CANNULAS GET DISCONNECTED OR DISLODGED. ENSURE THAT THE ACCESS TO THE PATIENT ALWAYS REMAINS FULLY VISIBLE DURING THERAPY. ENSURE THAT CANNULAS ARE ADEQUATELY FIXED. REGULARLY CHECK PATIENT ACCESS. VENOUS LOWER LIMIT SHOULD BE SET TO GREATER THAN OR EQUAL TO 20 MMHG IN TSM (TECHNICAL SERVICE MODE). IF THE VENOUS NEEDLE SLIPS OUT OR THE CONNECTION OF THE VASCULAR ACCESS DETACHES DURING TREATMENT, THE PATIENT'S BLOOD IS NO LONGER RETURNED TO THE PATIENT. INSTEAD, IT IS PUMPED TO THE ENVIRONMENT, WHILE BLOOD IS STILL BEING TAKEN FROM THE PATIENT THROUGH THE ARTERIAL NEEDLE. DEPENDING ON THE BLOOD FLOW RATE, THIS CAN LEAD TO A LIFE-THREATENING SITUATION WITHIN A SHORT TIME. AS OUTLINED ABOVE, IT IS STATE OF TECHNOLOGY THAT A NEEDLE DISLODGEMENT WILL NOT BE DETECTRF IN ANY CASE BY A DIALYSIS MACHINE, DEPENDENT ON THE PRESSURE DROP CAUSED BY THE NEEDLE DISLODGMENT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE FOR A DEFECT OR A MALFUNCTION OF THE DEVICE. 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 (B)(4). THE DIALOG+ DIALYSIS MACHINE WAS TECHNICALLY INSPECTED BY THE CUSTOMER'S TECHNICIAN AFTER THE DESCRIBED EVENT. IT WAS CONFIRMED THAT IT OPERATED AS INTENDED AND HAS BEEN CLEARED FOR USE BY THE CUSTOMER. DEPENDENT ON THE PRESSURE DROP AND THE ALARM LIMITS SET, THE PRESSURE MONITORING SYSTEM OF A DIALYSIS MACHINE DOES NOT RELIABLY DETECT A DISCONNECTION OR DISLODGEMENT OF THE VENOUS PATIENT ACCESS. THEREFORE, THE INSTRUCTIONS FOR USE OF THE DIALOG+ DIALYSIS MACHINE SHOWS THE FOLLOWING WARNING: RISK TO PATIENT DUE TO BLOOD LOSS IF CANNULAS GET DISCONNECTED OR DISLODGED! STANDARD MONITORING FUNCTION OF THE DIALYSIS MACHINE CANNOT ENSURE DETECTION IF THE CANNULAS GET DISCONNECTED OR DISLODGED. ENSURE THAT THE ACCESS TO THE PATIENT ALWAYS REMAINS FULLY VISIBLE DURING THERAPY. ENSURE THAT CANNULAS ARE ADEQUATELY FIXED. REGULARLY CHECK PATIENT ACCESS. VENOUS LOWER LIMIT SHOULD BE SET TO GREATER THAN OR EQUAL TO 20 MMHG IN TSM (TECHNICAL SERVICE MODE). 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: THE VENOUS LINE DETACHED FROM THE CATHETER TWO (2) HOURS INTO TREATMENT CAUSING SIGNIFICANT BLOOD LOSS OF 500+ ML. THE VENOUS PRESSURE READING OF THE DIALYSIS MACHINE WAS AROUND 200 MMHG DURING TREATMENT AND THEN DROPPED RAPIDLY TO 40 MMHG WHEN THE VENOUS LINE DETACHED. SINCE THE LOWER ALARM LIMIT OF THE DIALOG+ MACHINE WAS SET TO 20 MMHG, IT DID NOT TRIGGER AN ALARM. THE NURSE RESPONDED WITHIN ONE (1) MINUTE OF THE PRESSURE DROP TO FIND THAT THE VENOUS LINE HAD BECOME DISCONNECTED. THE SITE WAS NOT COVERED. IT WAS IN PLAIN SIGHT. THE PATIENT RECEIVED CPR AND WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT DID PASS AWAY SEVERAL DAYS LATER. PLEASE NOTE THAT THIS IS THE SAME PATIENT AND INCIDENT AS REPORTED IN MDR # 2521402-2021-00024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865684 DIALOG+ DIALYZER, HIGH PERMEABILIT KDI B. BRAUN AVITUM AG - MELSUNGEN 710200S 04046964285608

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H