BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO ELISIO-H DIALYZER

    MDR report key: 10865334 · Received November 18, 2020

    Report

    Report Number
    9610987-2020-00007
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 12, 2020
    Report Date
    January 28, 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

    Additional Manufacturer Narrative · 0

    11/20/2020: CORRECTED INITIAL SUBMISSION REPORT DATE FROM 10/19/2020 TO 11/18/2020.

    Additional Manufacturer Narrative · 0

    ON 11/20/2020: CORRECTED INITIAL SUBMISSION REPORT DATE FROM 10/19/2020 TO 11/18/2020.

    Description of Event or Problem · 0

    DURING DIALYSIS TREATMENT, MACHINE ALARMED FOR BLOOD LEAKAGE AND IT WAS CONFIRMED WITH A BLOOD LEAK TEST STRIP, 10 MINUTES INTO DIALYSIS TREATMENT. NO BLOOD RESTITUTION. PATIENT WAS ADMINISTERED GELO 300ML AND PERFALGAN THROUGH IV. PATIENT WAS MONITORED AND FELT WELL AFTER 1 HOUR. PATIENT'S HEALTH STATUS IS STABLE. DIALYSIS MACHINE WAS CHANGED FOR THE NEXT DIALYSIS SESSION.

    Description of Event or Problem · 0

    DURING DIALYSIS TREATMENT, MACHINE ALARMED FOR BLOOD LEAKAGE AND IT WAS CONFIRMED WITH A BLOOD LEAK TEST STRIP, 10 MINUTES INTO DIALYSIS TREATMENT. NO BLOOD RESTITUTION. PATIENT WAS ADMINISTERED GELO 300ML AND PERFALGAN THROUGH IV. PATIENT WAS MONITORED AND FELT WELL AFTER 1 HOUR. PATIENT'S HEALTH STATUS IS STABLE. DIALYSIS MACHINE WAS CHANGED FOR THE NEXT DIALYSIS SESSION.

    Description of Event or Problem · 1

    DURING DIALYSIS TREATMENT, MACHINE ALARMED FOR BLOOD LEAKAGE, AND IT WAS CONFIRMED WITH A BLOOD LEAK TEST STRIP, 10 MINUTES INTO DIALYSIS TREATMENT. NO BLOOD RESTITUTION. PATIENT WAS ADMINISTERED GELO 300ML AND PERFALGAN THROUGH IV. PATIENT WAS MONITORED, AND FELT WELL AFTER 1 HOUR. PATIENT'S HEALTH STATUS IS STABLE. DIALYSIS MACHINE WAS CHANGED FOR THE NEXT DIALYSIS SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329924 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) ELISIO-21H 20F25C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other