BEUDAMED
    FDA Adverse Event Summary report: N

    DIALOG A+HE/BIC

    MDR report key: 5074782 · Received September 14, 2015

    Report

    Report Number
    3002879653-2015-00011
    Date Received
    September 14, 2015
    Date of Event
    September 5, 2015
    Report Date
    September 8, 2015
    Manufacturer
    B. BRAUN AVITUM AG - MELSUNGEN
    Product Code
    FKJ
    PMA / PMN Number
    K963440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SEVERAL ATTEMPTS WERE MADE TO GET MORE DETAILED INFORMATION AND TO GET ACCESS TO THE DIALYSIS MACHINE FOR TECHNICAL INSPECTION. HOWEVER, THESE REQUESTS WERE DENIED BY THE FACILITY BECAUSE THE RISK MANAGEMENT DEPARTMENT WAS INVESTIGATING THE CASE. ADDITIONAL PHONE CALLS AND EMAIL FOLLOW UPS WERE MADE WITH TO THE FACILITY'S RISK MANAGEMENT DEPARTMENT TO OBTAIN INFORMATION ABOUT THE INCIDENT AND THE INVESTIGATION, AND ONCE AGAIN, NO INFORMATION WAS SHARED WITH B. BRAUN (B)(4) REGARDING THE INVESTIGATION. HOWEVER, DURING ONE OF THE PHONE CALLS, IT WAS COMMUNICATED VERBALLY "THAT THE DIALYSIS MACHINE WAS NOT SUSPECTED TO HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH." ALL AVAILABLE INFORMATION ASSOCIATED WITH THIS EVENT WAS FORWARDED TO THE EQUIPMENT MANUFACTURER B. BRAUN (B)(4). THE MACHINE TREND FILES WERE SUBMITTED TO THE MANUFACTURER FOR THEIR REVIEW. BASED ON THE REVIEW OF THIS INFORMATION THE MANUFACTURER INDICATES THAT THE ANALYSIS OF THE DATA FILES SHOWED THAT THE THERAPY TERMINATED PREMATURELY AFTER 23 MINUTES. DURING THE THERAPY THE ARTERIAL PRESSURE, MEASURED BY THE MACHINE DECREASED CONTINUOUSLY AND THE VENOUS PRESSURE INCREASED LEADING TO MULTIPLE PRESSURE ALARMS. DUE TO THESE ALARMS, THE DIALYSIS MACHINE SWITCHED INTO PATIENT-SAFE MODE. THE BLOOD PUMP STOPPED, THE SAFETY AIR CLAMP CLOSED AND THE MACHINE OPERATED IN BYPASS MODE. THE ALARMS WERE QUICKLY ACKNOWLEDGED BY THE OPERATOR AND THE THERAPY CONTINUED UNTIL IT WAS TERMINATED PREMATURELY BY THE OPERATOR. THE TREND DATA ANALYSIS SHOWS THAT THE DIALOG+ DIALYSIS MACHINE OPERATED AS INTENDED. THERE WAS NO MALFUNCTION. BASED UPON THE REVIEW OF THE TREND FILE AND INFORMATION COMMUNICATED BY THE FACILITY, THE UNIT OPERATED AS INTENDED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IN A FOLLOW UP WITH THE FACILITY, THE REPORTER STATED THAT THEIR RISK MANAGEMENT DEPARTMENT CAN NOT RELEASE THE ACTUAL DEVICE AND/ OR ANY INFORMATION AT THIS TIME FOR EVALUATION PENDING THE RESULTS OF THEIR INTERNAL EVALUATION. THE INVESTIGATION IS ON-GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE EVALUATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: ON 9/8/2015 CUSTOMER BIOMED REPORTED THAT A PATIENT EXPIRED DURING THERAPY ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607823 DIALOG A+HE/BIC HEMODIALYSIS SYSTEM FKJ B. BRAUN AVITUM AG - MELSUNGEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R