BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBB-05 HEMODIALYSIS DELIVERY SYSTEM

    MDR report key: 10982710 · Received December 10, 2020

    Report

    Report Number
    8031561-2020-00004
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    September 5, 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

    FROM OUR LOCAL DISTRIBUTOR WE RECEIVED THE FOLLOWING INFORMATION AS TO THE REPORTED EVENT. "SECOND OCCURRENCE OF THIS ALARM WHERE CONDUCTIVITY ISSUES IN THIS CASE ACID CANISTER EMPTY MAY HAVE CAUSED THE FAULT. FROM THE ALARM HISTORY THE MACHINE FIRST HAD AN ISSUE DUE TO THE EMPTY ACID AND THEN THE TREATMENT HAS BEEN STOPPED AND RESTARTED 4 TIMES IN 5 MINUTES. EVENTUALLY BEING CHANGED TO HD MODE AND THE PATIENT BEING RUN BACK BEFORE THE 141 ALARM OCCURRED. THE AIR BEING DRAWN IN FROM THE EMPTY CANNISTER AND FROM THE HD CHANGE OVER ARE BELIEVED TO HAVE CONTRIBUTED TO THE 141 EXTRA AIR REMOVED ALARM. MACHINE HAS BEEN IN USE FOR TWO DAYS SINCE THE ALARM WITHOUT FAULT AND AN ADDITIONAL TEST THERAPY HAS BEEN RUN IN THE WORKSHOP WITHOUT ANY PROBLEMS AND WITH THE UF REMOVAL BEING FOUND TO BE EXACT. UNIT HEAT CLEANED AND RETURNED TO USE." BASED ON THE ABOVE INFORMATION, WE EVALUATED THAT THE REPORTED EVENT WAS NOT ADVERSE EVENT AND THERE WAS NO MALFUNCTION OF THE MACHINE.

    Description of Event or Problem · 1

    MACHINE ISSUED ALARM TFD141 (SUSPECTED FAULTY FLOAT CELL) WHICH RESULTED IN PATIENT BEING DISCONNECTED FROM MACHINE. THIS ALARM IS DESIGNED TO PICK UP A FAILED FLOAT AND ALERT THE USER TO THE ISSUE. IT CAN ONLY DO THIS BY TIMING A RELEASE VALVE AND IF THE VALVE IS OPEN FOR MORE THAN 60 SECONDS IN A THERAPY OR 5 SECONDS OUT OF 10 IT DETERMINES THIS TO HAVE BEEN TOO LONG AND FLAGS THE ALARM. THE VALVE OPENS TO EXPEL ANY AIR THAT HAS ENTERED THE SYSTEM. THIS IS NOT DETRIMENTAL TO THE PATIENT BUT CAN STILL TRIGGER THE TFD141 ALARM IF MORE THAN NORMAL IS OBSERVED. SO WHAT HAS HAPPENED IS THE ALARM THAT WOULD JUST HAVE BEEN RESET IN THE PAST IS NOW CAUSING THE MACHINE TO BE PULLED THE FLOAT AND ADVERSE EVENT REPORT STARTED AS THE CUSTOMER IS UNSURE IF THEY HAVE AN ACTUAL FAILED FLOAT OR JUST SOME EXTRA AIR IN THE SYSTEM. THE FAILED FLOATS WERE INTERMITTENT AND WERE CAPABLE OF FUNCTIONING CORRECTLY FOR DAYS BEFORE ALARMING AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451847 DBB-05 HEMODIALYSIS DELIVERY SYSTEM HIGH PERMEABILITY HEMODIALYZER KDI NIKKISO CO.,LTD DBB-05 N/A

    Patients

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