BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALOG+® 

    MDR report key: 6864693 · Received September 14, 2017

    Report

    Report Number
    3002879653-2017-00013
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    September 12, 2017
    Report Date
    September 12, 2017
    Manufacturer
    B. BRAUN AVITUM, AG - MELSUNGEN
    Product Code
    KDI
    UDI-DI
    04046964285615
    PMA / PMN Number
    K083460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015012. B. BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN AVITUM AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN AVITUM INTERNAL REPORT # (B)(4). INITIAL INFORMATION WAS RECEIVED FROM THE FACILITY BIOMED. THE MACHINE TREND FILE AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FACILITY AND THE INVESTIGATION IS ON-GOING 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: 5 MINUTES INTO THE START OF TREATMENT A PATIENT HAS A CARDIAC ARREST. THE PATIENT STATUS HAS NOT BEEN GIVEN BY THE USER FACILITY. THE BIO MED TECHNICIAN STATED WHEN THE TREATMENT ENDED HE WAS ASKED TO TAKE DIALYSATE SAMPLES TO SEND TO THE LAB. WHEN HE GOT TO THE MACHINE IT WAS IN BYPASS AND DID NOT KNOW FOR HOW LONG. HE THEN TESTED THE FUNCTION OF THE BLOOD LEAK DETECTOR FOR PROPER OPERATION AND IT WAS WORKING WITHIN SPECIFICATIONS. THE BIO MED TECHNICIAN INDICATED THEY WOULD RUN A MOCK TREATMENT TO OBTAIN SAMPLES BEFORE AND AFTER THE EVENT.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2015012. (B)(4). NO FURTHER INFORMATION OR TREND DATA RECORDS WERE PROVIDED FOR THE DIALOG+ MACHINE. THE INFORMATION THAT WAS PROVIDED AND THE INSPECTION OF THE DIALOG+ MACHINE BY THE BIOMED TECHNICIAN DOES NOT GIVE ANY EVIDENCE OF A PRODUCT FAILURE. END STAGE RENAL DISEASE (ESRD) AS CAUSE FOR CARDIAC DISEASE IS DESCRIBED FREQUENTLY IN THE MEDICAL LITERATURE AND CARDIOVASCULAR DISEASE LEADING TO CARDIAC ARREST IS THE MOST COMMON CAUSE OF DEATH IN DIALYSIS AND ESRD PATIENTS. SEVERE CARDIAC EVENTS, INCLUDING CARDIAC ARREST, DO OCCUR DURING DIALYSIS THERAPY AND ARE RELATED TO THE UNDERLYING DISEASE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643922 DIALOG+®  HIGH PERMEABILIT KDI B. BRAUN AVITUM, AG - MELSUNGEN 710200U 04046964285615

    Patients

    Seq Age Sex Outcome Treatment
    1 Other