BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALOG A + HE/BIC

    MDR report key: 5354540 · Received January 8, 2016

    Report

    Report Number
    3002879653-2015-00016
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Date of Event
    December 9, 2015
    Report Date
    December 18, 2015
    Manufacturer
    B. BRAUN AVITUM AG - MELSUNGEN
    Product Code
    FKJ
    PMA / PMN Number
    K083460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER 2015012. 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 MEDICAL INTERNAL REPORT NUMBER (B)(4). EVENT 2: THE CUSTOMER HAD REPORTED THAT BETWEEN 2015-12-09 AND 2015-12-11, ON FOUR PATIENTS THE WEIGHT AFTER DIALYSIS WAS 1.9 KG, 0.3KG, 3.06 KG, AND 2.3 KG BELOW TARGET WEIGHT. UPON REQUEST, THE CUSTOMER DID NOT DISCLOSE WHETHER ANY MEDICAL INTERVENTION WAS NECESSARY. THE CUSTOMER SUSPECTED THE ABOVE-MENTIONED DIALOG+ DIALYSIS MACHINE TO BE RESPONSIBLE FOR THE OVERFILTRATION. THE DIALOG+ DIALYSIS MACHINE WAS INSPECTED BY THE CUSTOMER'S TECHNICIAN AND TWO MOCK THERAPIES WERE ACCOMPLISHED DURING WHICH THE ULTRAFILTRATION WAS MEASURED. THERE WAS NO MALFUNCTION AND NO DEVIATION IN THE ULTRAFILTRATION. TEN TREND DATA RECORDS OF THE ABOVE MENTIONED DIALOG+ MACHINE HAD BEEN PROVIDED BY THE CUSTOMER. SIX OF THESE DATA SETS SHOWED THERAPY RECORDS, THE OTHER FOUR EITHER A PREPARATION PHASE OR A DISINFECTION CYCLE. THE TREND DATA RECORDS COULD NOT BE ASSIGNED TO A SPECIFIC EVENT OR PATIENT BECAUSE THE CUSTOMER'S CORPORATE FACILITY DID NOT ALLOW THERAPY PROTOCOLS OR SPECIFIC PATIENT INFORMATION TO BE PROVIDED. FOUR OF THE TREND RECORDS SHOW A THERAPY WHICH WAS TERMINATED PREMATURELY, IN THREE OF THESE THERAPIES MINIMAL UF HAD BEEN ACTIVATED. THE ANALYSIS OF THE TREND DATA RECORDS DO NOT GIVE ANY EVIDENCE OF A MALFUNCTION OR A PRODUCT DEVIATION OF THE DIALOG+ DIALYSIS MACHINE. SINCE THERE IS NO PRODUCT DEVIATION, THE COMPLAINED OVERFILTRATION MIGHT BE DUE TO OTHER KNOWN REASONS WHICH ARE THE WEIGHING PROCEDURE BEFORE AND AFTER DIALYSIS, THE RESIDUAL RENAL FUNCTION OF A PATIENT OR THE ACTUAL FLUID AND FOOD INTAKE OF A PATIENT DURING DIALYSIS. SINCE NEITHER THE INSPECTION OF THE DIALOG+ DIALYSIS MACHINE ON-SITE NOR THE EVALUATION OF THE TREND DATA RECORD GIVES ANY EVIDENCE OF A MALFUNCTION OR PRODUCT DEVIATION, NO FURTHER MEASURES WILL BE INITIATED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    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 MEDICAL INTERNAL REPORT NUMBER (B)(4). IN A FOLLOW UP WITH THE FACILITY, IT WAS COMMUNICATED THAT THE CUSTOMER'S BIOMED TECHNICIAN RAN TWO SIMULATED THERAPIES WITH NO DEVIATIONS TO THE UF RESULT. BASED ON THIS, THE TECHNICIAN STATED THAT HE DID NOT THINK IT WAS A MACHINE PROBLEM. ADDITIONALLY, THE NURSE MANAGER COMMUNICATED THAT NO MALFUNCTIONS WERE NOTED; NO UNUSUAL ALARMS NOTED IN DOCUMENTATION. THE INVESTIGATION INTO THE REPORTED EVENT IS ON GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE RESULTS OF THE EVALUATION BECOME AVAILABLE.

    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 MEDICAL INTERNAL REPORT NUMBER (B)(4). CORRECTION - TYPOGRAPHICAL ERROR : CHANGE FROM :UF/IMPORTER REPORT #: (B)(4).

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: EVENT #3: CUSTOMER CALLED REPORTING AN INCIDENT RELATED TO ULTRIFILTATION PROBLEMS WITH THE MACHINE. THE CUSTOMER HAS RETRIEVED TRENDS FROM 4 PATIENT RUNS THAT HAVE REPORTED PROBLEMS {[...] THE PATIENTS COMPLAINED OF CRAMPING. EMS WAS NOT REQUIRED ON ALL 4 ACCOUNTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12830 DIALOG A + HE/BIC HEMODIALYSIS SYSTEM FKJ B. BRAUN AVITUM AG - MELSUNGEN N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1