BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBB-06 HEMODIALYSIS DELIVERY SYSTEM

    MDR report key: 10982664 · Received December 10, 2020

    Report

    Report Number
    8031561-2020-00002
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    June 23, 2014
    Report Date
    December 10, 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

    ON OCTOBER 14, 16 AND 17 IN 2014, OUR REPRESENTATIVE FROM NIKKISO VISITED THE FACILITY ON AND CHECKED THE WORKING CONDITION OF DBB-06 (69050-04)(ADJUSTING PRESSURE, DRAIN PRESSURE, DRAIN HIGHT,BALANCE(DISCHARGE/SUCTION),AIR REMOVAL FROM GAS CHAMBER(GC2),THE LEAKAGE FROM DIALYSIS FLUID FILTER (FL1), THE SETTING OF FL1) AND 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,AND THE ABNORMAL SERVICE HISTORY ON THE DBB-06 (69050-04). FURTHERMORE THE SIMULATED TREATMENT WAS PERFORMED TO CHECK THE MACHINE CONDITION. AS A RESULT OF THE CHECK, WE REALIZED THAT DIALYSIS FLUID FILTER (FL1) WAS LEAKED AND IN DIFFERENT FROM THE ORIGINAL SPECIFICATION. INFLOW OF AIR INTO THE FL1 WAS TRAPPED BY THE GC2 UNDER THE NEGATIVE PRESSURE CONDITION CREATED BY THE UF PUMP. IT WAS OBSERVED THAT THE INFLOW OF AIR INTO THE FL1 WAS INCREASED IN CORRESPONDENCE TO AN INCREMENT OF THE UF RATE, AND THE SMALL AMOUNT OF THE AIR WENT THROUGH CONTINUOUSLY AND WAS TRAPPED BY THE GC2 BUT NOT DUPLICATED THE "TFD141 ALARM"(SEE THE ATTACHMENT I). FROM THE ABOVE RESULTS, WE ASSUME THAT IT WAS OCCURRED DUE TO THE FL1 SETTING BY MISUSE. WE HAVE SOLD 3399 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 0.03%.

    Description of Event or Problem · 1

    ON (B)(6) 2014, MACHINE BELIEVED TO HAVE REMOVED EXCESS FLUID FROM PATIENT. REPORTED TO BE 1KG UNDER DRY WEIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450072 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