BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALOG®

    MDR report key: 15209399 · Received August 11, 2022

    Report

    Report Number
    3002879653-2022-00021
    Event Type
    Death
    Date Received
    August 11, 2022
    Date of Event
    July 13, 2022
    Report Date
    November 10, 2022
    Manufacturer
    B. BRAUN AVITUM AG
    Product Code
    KDI
    UDI-DI
    04046963686345
    Adverse Event
    Yes
    Report Source
    Manufacturer 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 COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE 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 CODED DURING A TREATMENT WITH A DIALOG+ DIALYSIS MACHINE AND PASSED AWAY. AS PER FACILITY POLICY THE CUSTOMER REQUESTED AN EVALUATION OF THE DIALYSIS MACHINE BY THE MANUFACTURER. THE PRODUCT INVOLVED IN TEH REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. THE DATA RECORD OF THE DIALOG+ MACHINE COULD NOT BE PROVIDED, BUT AS REQUESTED BY THE CUSTOMER, THE DIALYSIS MACHINE WAS TECHNICALLY INSPECTED BY A B. BRAUN ENGINEER. THE INSPECTION DID NOT SHOW ANY MALFUNCTION, IT OPERATED AS INTENDED. CONTRARY TO THE INITIAL INFORMATION IS WAS CONFIRMED THAT THE PATIENT DID NOT PASS AWAY DURING THERAPY BUT AFTERWARDS. AFTER THE PATIENT WAS TREATED, TWO OTHER PATIENTS WERE TREATED WITH THE SAME DIALOG+ MACHINE WITHOUT ANY ISSUE. FURTHER INVESTIGATION OF THE COMPLAINT WAS NOT POSSIBLE WITHOUT A SAMPLE DEVICE. SINCE THERE WAS NO PRODUCT DEVIATION, NO FURTHER ACTION WILL WAS TAKEN.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A PATIENT CODED DURING A TREATMENT WITH A DIALOG+ DIALYSIS MACHINE AND PASSED AWAY. AS PER FACILITY POLICY THE CUSTOMER REQUESTED AN EVALUATION OF THE DIALYSIS MACHINE BY THE MANUFACTURER. THE FEMALE PATIENT WAS A 74 YEAR OLD WITH A HISTORY OF HYPERTENSION, DIABETES, AND END-STAGE RENAL DISEASE PRESENTED DUE TO GENERALIZED WEAKNESS AND ELEVATED BLOOD PRESSURE. DURING LIVER FUNCTION TESTS (LFTS) INCREASED PARAMETERS WERE NOTED. SHE WAS EVENTUALLY FOUND TO HAVE ACUTE CHOLECYSTITIS AND UNDERWENT SURGERY ON (B)(6). THE PATIENT WAS ON DIALYSIS FOR 2.5 HOURS. SHE WAS LETHARGIC BUT AROUSABLE AND CONVERSANT WITH A BLOOD PRESSURE OF 118/60 AT 20:25. AT 20:55 THE STAFF WAS UNABLE TO OBTAIN A BLOOD PRESSURE AND THE PATIENT WAS UNRESPONSIVE WITH SHALLOW AND SLOW RESPIRATORY RATE. THE STAFF AUSCULTATED A FAINT HEARTBEAT. THE PATIENT WAS PLACE IN TRENDELENBURG POSITION, TREATMENT WAS STOPPED, AND HER BLOOD WAS RETURNED TO HER ALONG WITH AN ADDITION OF 200 ML NORMAL SALINE. RRT WAS CALLED. RRT WAS ALSO ABLE TO AUSCULTATE A FAINT HEARTBEAT. PATIENT WAS AN ALLOW NATURAL DEATH, SO CPR WAS NOT INITIATED. CAUSE OF DEATH: CARDIOPULMONARY ARREST. THE DIALOG+ MACHINE WAS USED FOR 2 TO 3 THERAPIES WITHOUT ANY ISSUE AFTER THE EVENT DESCRIBED ABOVE. IN THE TECHNICAL INSPECTION BY A B. BRAUN ENGINEER DID NOT SHOW ANY MALFUNCTION OF THE DIALOG+ DIALYSIS MACHINE, IT OPERATED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1785104 DIALOG® HIGH PERMEABILIT KDI B. BRAUN AVITUM AG 710200L 04046963686345

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Death