BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO ELISIO-H DIALYZER

    MDR report key: 10865448 · Received November 18, 2020

    Report

    Report Number
    9610987-2020-00008
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 7, 2020
    Report Date
    April 5, 2021
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    PMA / PMN Number
    K131935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    PATIENT EXPERIENCED 3 INCIDENTS INVOLVING BLOOD LEAK ALARMS DURING DIALYSIS TREATMENT. 1ST INCIDENT (B)(6) 2020: 1.45HOURS INTO DIALYSIS TREATMENT MACHINE ALARMED FOR BLOOD LEAK. TREATMENT INTERRUPTED. 2ND INCIDENT (B)(6) 2020: 1.45 MINUTES INTO HEMODIALYSIS TREATMENT, MACHINE ALARMED FOR BLOOD LEAK. PATIENT HAD LOW BLOOD PRESSURE AFTER BLOOD LOSS FROM THE CIRCUIT, AROUND 300ML. SECOND MACHINE WAS SET UP, SAME ISSUE OCCURRED, PATIENT EXPERIENCED DISCOMFORT. ULTRAFILTRATION WAS STOPPED. BLOOD RESTITUTION WAS DONE. PATIENT WAS SENT TO THE ER, PATIENT'S HEALTH STATUS WAS STABLE. 3RD INCIDENT (B)(6) 2020: 50 MINUTES INTO TREATMENT, MACHINE ALARMED FOR BLOOD LEAK AND CONFIRMED WITH BLOOD LEAK TEST STRIP. BLOOD RESTITUTION DONE. STAFF CHANGED THE CIRCUIT AND DIALYSIS MACHINE.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED 3 INCIDENTS INVOLVING BLOOD LEAK ALARMS DURING DIALYSIS TREATMENT. 1ST INCIDENT (B)(6) 2020: 1.45HOURS INTO DIALYSIS TREATMENT MACHINE ALARMED FOR BLOOD LEAK. TREATMENT INTERRUPTED. 2ND INCIDENT (B)(6) 2020: 1.45 MINUTES INTO HEMODIALYSIS TREATMENT, MACHINE ALARMED FOR BLOOD LEAK. PATIENT HAD LOW BLOOD PRESSURE AFTER BLOOD LOSS FROM THE CIRCUIT, AROUND 300ML. SECOND MACHINE WAS SET UP, SAME ISSUE OCCURRED, PATIENT EXPERIENCED DISCOMFORT. ULTRAFILTRATION WAS STOPPED. BLOOD RESTITUTION WAS DONE. PATIENT WAS SENT TO THE ER, PATIENT'S HEALTH STATUS WAS STABLE. 3RD INCIDENT (B)(6) 2020: 50 MINUTES INTO TREATMENT, MACHINE ALARMED FOR BLOOD LEAK AND CONFIRMED WITH BLOOD LEAK TEST STRIP. BLOOD RESTITUTION DONE. STAFF CHANGED THE CIRCUIT AND DIALYSIS MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330277 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) ELISIO-21H 20E21C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other