BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO ELISIO-H DIALYZER (90, 250)

    MDR report key: 11676059 · Received April 15, 2021

    Report

    Report Number
    9610987-2021-00004
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 15, 2021
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    PMA / PMN Number
    K140191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF RESPIRATORY DISCOMFORT 30 MINUTES AFTER THE START OF DIALYSIS TREATMENT. THE BLOOD PRESSURE DROPPED TO 70 AND SPO2 BECAME 87%. OXYGEN WAS ADMINISTERED. ACTUAL LOT NUMBER IS UNKNOWN. POSSIBLE LOT NUMBERS 20L10E OR 21A21E. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567433 NIPRO ELISIO-H DIALYZER (90, 250) DIALYZER KDI NIPRO CORPORATION (ODT) ELISIO-25H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other