BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALOG®

    MDR report key: 14401311 · Received May 13, 2022

    Report

    Report Number
    2521402-2022-00031
    Event Type
    Death
    Date Received
    May 13, 2022
    Date of Event
    April 20, 2022
    Report Date
    May 12, 2022
    Manufacturer
    B. BRAUN AVITUM AG
    Product Code
    KDI
    UDI-DI
    04046963686345
    PMA / PMN Number
    K083460
    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 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 · 0

    AS REPORTED BY THE USER FACILITY: PATIENT PULLED /REMOVED TUBING FROM "PERMACATH" FEED ON THEIR OWN AND THE MACHINE DID NOT ALARM AS REPORTED BY THE CALLER. PATIENT HAD A PERMCATH CENTRAL VENOUS CATHETER. TREATMENT WAS ON (B)(6) 2022. START TIME 13:00 END TIME 16:10. SERVICE REPORT ATTACHED. LINE 5.6 ON THE ATTACHED SERVICE REPORT INDICATES THAT THE SAD WAS TESTED AND IT FUNCTIONALLY PASSED. PATIENT BECAME UNRESPONSIVE AND LOOKED AS HE WAS HAVING A SEIZURE. HE WAS SENT TO CT WHICH INDICATED AN EXTENSIVE CEREBRAL VENOUS GAS. MEDICAL INTERVENTION APART FROM SENDING THE PATIENT TO THE ICU: PLACING IN TRENDELENBURG POSITION AND HIGH FLOW OXYGENATION. PATIENT DISCONNECTED HIMSELF FROM DIALYSIS AT THE CONNECTION SITE WHERE THE DIALYSIS TUBING ATTACHES TO THE PORTCATH ARTERIAL PORT. BRAUN STREAMLINE AIRLESS SYSTEM SET FOR B. BRAUN DIALOG MACHINES WAS USED. PATIENT OUTCOME: FAMILY ELECTED TO WITHDRAWAL CARE, AND PATIENT EXPIRED. DIAGNOSIS IN THE ICU: ACUTE EMBOLISM STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836726 DIALOG® HIGH PERMEABILIT KDI B. BRAUN AVITUM AG 710200L 04046963686345

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death