BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBB-06 HEMODIALYSIS DELIVERY SYSTEM

    MDR report key: 11073619 · Received December 25, 2020

    Report

    Report Number
    8031561-2020-00008
    Event Type
    Injury
    Date Received
    December 25, 2020
    Date of Event
    February 11, 2019
    Report Date
    December 26, 2020
    Manufacturer
    NIKKISO CO.,LTD
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DIALYSIS TREATMENT 4:00 HRS START AT 09:20. DIALYSIS TREATMENT WAS STOPPED AT 10:06. DIALYSIS STOPPED WITHIN 40 MINUTES AFTER STARTING DUE TO TFD141 FLOAT SWITCH ABNORMAL. EARLIER EXPERIENCES OF UF EXCESS REMOVED TECHNICIAN STOPPED DIALYSIS FOR SAFETY FROM HIS EXPERIENCE OF UF REMOVAL EXCESS. UF GOAL SET 2800ML FOR 4 HRS. UF REMOVED DISPLAY400 ML DURING 0:40 MINUTES OF DIALYSIS, BUT ACTUAL REMOVAL OF THE PATIENT WAS 800ML. PATIENT CONDITION WAS NORMAL. WE CHANGED GAS SEPARATOR 2.TO NEW ONE AND THE MACHINE WENT BACK TO ORIGINAL CONDITION. BACK PRESSURE VALVE H1 WAS CALIBRATED. BACK PRESSURE VALVE H2 WAS CALIBRATED. VALVE L WAS CALIBRATED (BALANCE CHECK WITH 20ML DONE). SELF-TEST PASSED. SIMULATION OF THE DIALYSIS TREATMENT WITH SALINE TO CONFORM 100% ACCURACY ON UF REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537833 DBB-06 HEMODIALYSIS DELIVERY SYSTEM HIGH PERMEABILITY HEMODIALYZER KDI NIKKISO CO.,LTD DBB-06 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other