BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBB-05 HEMODIALYSIS DELIVERY SYSTEM

    MDR report key: 10982745 · Received December 10, 2020

    Report

    Report Number
    8031561-2020-00006
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    August 20, 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

    Description of Event or Problem · 1

    PATIENT WAS PLACED ON HDF MACHINE FOR REGULAR TREATMENT (CONTINUED). NO ALARMS DURING PRIMING OR SELF-TESTING. 30 MINUTES INTO TREATMENT, MACHINE ALARMED WITH "FLOAT SENSOR ALARM", THE PATIENT WAS TAKEN OFF THE MACHINE IMMEDIATELY AND THE MACHINE REMOVED FROM THE TREATMENT AREA AND THE FAULT REPORTED TO BAXTER. HAVING TO TAKE THE PATIENT OFF THE MACHINE RESULTED IN THE PATIENT LOSING ONE CIRCUIT BLOOD, APPROXIMATELY 300MLS. SAMPLE OF HEMOGLOBIN WAS COLLECTED AND TREATING NEPHROLOGIST WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452969 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