BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 200NR DIALYZER

    MDR report key: 2400993 · Received January 4, 2012

    Report

    Report Number
    1713747-2012-00001
    Event Type
    Injury
    Date Received
    January 4, 2012
    Date of Event
    December 2, 2011
    Report Date
    January 4, 2012
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K002277
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    AN ACUTE HEMODIALYSIS UNIT HAS REPORTED A POSSIBLE PT REACTION TO THE OPTIFLUX DIALYZER. THE PT WAS ADMITTED TO THE HOSP ON (B)(6) 2011, WITH A CHIEF COMPLAINT OF ABDOMINAL PAIN, CHEST PAIN AND SOB. THIS PT HAS BEEN ON HEMODIALYSIS FOR OVER 4 YEARS AND DIALYSIS VIA A RUA AV GRAFT. ON (B)(6) 2011, THE DIALYZER WAS PRIMED WITH 3 LITERS OF NS AND THE PT WAS PRE-MEDICATED WITH IV BENADRYL AND DECADRON. WITHIN THE FIRST 15 MINUTES THE PT EXPERIENCED A RESPIRATORY ARREST WITH RESPIRATORY DEPRESSION, LOC AND DECREASED HEART RATE. SHE WAS RESUSCITATED SUCCESSFULLY AND HAS SINCE BEEN PLACED ON A CELLULOSE DIALYZER AND IS REPORTEDLY DOING WELL. SHE WAS DISCHARGED FROM THE HOSP ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 200NR DIALYZER HEMODIALYSIS DIALYZER KDI OGDEN MANUFACTURING NA 11NU04009

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R