BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO ELISIO-H DIALYZER

    MDR report key: 17452635 · Received August 3, 2023

    Report

    Report Number
    9610987-2023-00004
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    July 3, 2023
    Report Date
    August 3, 2023
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    PMA / PMN Number
    K140191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    2 HOURS AND 30 MINUTES INTO TREATMENT, PATIENT EXPERIENCED A LEVEL 3 ANAPHYLACTIC REACTION WITH SYMPTOMS OF DYSGEUSIA, ABDOMINAL PAIN, MALAISE, PALLOR, SWEATING, BRONCHOSPASM, HYPOTA WITH 98% SATURATION LEVEL. PHYSICIAN DECIDED TO STOP THE USE OF THE ELISIO-H DIALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325187 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) ELI-25H-POL-GJ 22J13E

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other