BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBB-06 HEMODIALYSIS DELIVERY SYSTEM

    MDR report key: 10982618 · Received December 10, 2020

    Report

    Report Number
    8031561-2020-00001
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    July 26, 2014
    Report Date
    October 12, 2020
    Manufacturer
    NIKKISO CO.,LTD
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT OF VISITING AT THE FACILITY. OUR ENGINEER VISITED THE FACILITY ON OCT (B)(6) 2014 AND CHECKED THE SETTING (QD SET, QB MONITOR, SUB GOAL, PRE WEIGHT, UF GOAL SET, BOLUS, POST WEIGHT AND UF ERROR), TFD141 ALARM RESET TIMES, ALARM LOGS OTHER THAN TFD141, THE LEAKAGE FROM DIALYSIS FLUID FILTER (FL1), THE SETTING OF FL1 AND THE ABNORMAL SERVICE HISTORY ON THE DBB-06 (69003-02). AS A RESULT OF THE CHECK, WE REALIZED THAT TFD141 ALARM WAS OCCURRED ONE TIME AND THE SETTING OF FL1WAS IN DIFFERENT FROM THE ORIGINAL SPECIFICATION. IN THE CASE, AIR STAYS INSIDE FL1 AND CAUSED TFD141 ALARM. ANALYSIS RESULT OF THE RETURNED FLOAT SWITCH PRODUCT: WE CONDUCTED AN INVESTIGATION OF THE RETURNED SWITCH INSTALLED ON THE DBB-06 (69003-02) AND CHECKED THE APPEARANCE, THE ELECTRIC RESISTANCE TEST, AND THE SIMULATED DIALYSIS TEST COMBINED WITH THE ACTUAL MACHINE FOR FIVE HOURS. AS A RESULT, WE COULD NOT DUPLICATE THE PROBLEM. ANALYSIS OF COMPLAINT RECORD: FROM THE ABOVE RESULTS, WE ASSUME THAT IT WAS OCCURRED DUE TO THE FL1 SETTING BY MISUSE. WE HAVE SOLD (B)(4) UNITS OF DBB-06 AS DEC 2015 GLOBALLY AND WERE INFORMED THIS COMPLAINT FROM THIS FACILITY ONLY AND WE HAVE NO OTHER INCIDENT REPORT FROM OTHER FACILITIES. THE OCCURRENCE RATE IS APPROXIMATELY (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, A MACHINE ALARM "TFD141 FLOAT SWITCH ABNORMAL" WAS RAISED 30 MINUTES INTO THE PATIENT'S 4 HOUR HAEMODIALYSIS TREATMENT. THE NURSE REFERRED TO "NIKKISO DBB 06 USER GUIDE" AND HAD RESET THE ALARM AS RECOMMENDED. AFTER 1 HR INTO TREATMENT, BLOOD VOLUME ALARM SHOWED GREATER THAN 20% FLUID LOSS. THE NURSE CHECKED THE PATIENT'S BLOOD PRESSURE AND FOUND IT DROPPED FROM 190/70 TO 118/60. THE PATIENT COMPLAINED OF FEELING UNWELL. SUBSEQUENTLY, ULTRAFILTRATION RATE (A TERM FOR THE RATE OF FLUID REMOVAL) WAS MINIMIZED, PATIENT WAS LAID FLAT AND 200ML NORMAL SALINE WAS GIVEN WITH GOOD EFFECT. THE TREATMENT WAS CONTINUED. "TFD141 FLOAT SWITCH ABNORMAL" ALARM REPEATED THREE TIMES FOR WHICH THEY WERE RESET AS RECOMMENDED BY THE MACHINE USER GUIDE. THE TREATMENT WAS DISCONTINUED WHEN IT ALARMED THE FOURTH TIME, PATIENT'S BLOOD RETURNED AND MACHINE REPLACED. THE MACHINE WAS ORIGINALLY SET TO REMOVE 2.2L OF FLUID FROM THE PATIENT; HOWEVER THE POST DIALYSIS WEIGHT LOSS MEASUREMENT INDICATED 3 KG WHICH MEANT MORE FLUID WAS REMOVED THAN PRESCRIBED. THIS WAS NOTED TO THE TECHNICIAN. THE TECHNICIAN BELIEVED THAT THE LARGE WEIGHT LOSS COULD NOT BE CAUSED BY THE MACHINE, BUT INDICATED THIS WILL BE REPORTED TO NIKKISO JAPAN FOR INVESTIGATION. ON (B)(6) 2014, THE TECHNICIAN CLARIFIED THAT THE WEIGHT LOSS COULD HAVE BEEN CAUSED BY THE MACHINE, EXPLAINING THAT "TFD141 ALARM" IS ACTIVATED AFTER AN ACCUMULATION OF 60 SECONDS OF GAS PURGE TIME IS RECORDED DURING A THERAPY AND IN THE EVENT OF A FLOAT SWITCH ERROR IT IS POSSIBLE SOME FLUID COULD BE LOST TO THE DRAIN . EACH TIME THE RESET BUTTON IS USED THE ALARM TIMER IS ALSO RESET, ALLOWING MORE FLUID TO BE DRAINED. A RECOMMENDATION WAS MADE NOT TO RESET THE MACHINE AS ORIGINALLY INSTRUCTED, AND INSTEAD TO REMOVE THE MACHINE FROM THE FLOOR IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447297 DBB-06 HEMODIALYSIS DELIVERY SYSTEM HIGH PERMEABILITY HEMODIALYZER KDI NIKKISO CO.,LTD DBB-06 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other BLOOD TUBING LINE: AV06JE-PDIALYZER