BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 160NRE DIALYZER

    MDR report key: 2140926 · Received June 21, 2011

    Report

    Report Number
    1713747-2011-00021
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    March 29, 2011
    Report Date
    June 21, 2011
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PT PRESENTED AMBULATORY TO THE HEMODIALYSIS CLINIC ON (B)(6) 2011, NO COMPLAINT BP 204/85. DIALYZER RINSED WITH 2000 ML'S OF NORMAL SALINE AS ORDERED. TREATMENT WAS INITIATED WITH CRITLINE ON WITHOUT ANY PROBLEMS, PT ON O2 AT 3 LPM VIA NASAL CANNULA, UFR OFF, BLOOD FLOW RATE AT 200 AND BENADRYL 25MG ADMINISTERED IV AS ORDERED. FIVE MINUTES INTO THE TREATMENT, BP DROPPED TO 139/69 AND PT BECAME ANXIOUS, BLOOD RETURNED IMMEDIATELY. REPORTEDLY, WITHIN A MATTER OF APPROXIMATELY A FEW MINUTES, PT WENT TO FULL SYNCOPE, THEN TO NO PULSE AND NO BREATHING. 911 WAS ACTIVATED AND CPR INITIATED, AED ATTACHED AND NO SHOCK INDICATED. CPR CONTINUED FOR ABOUT 3-4 MINUTES AND THE PT WAS ABLE TO BE REVIVED. 911 CAME AND TOOK OVER AND THE ER WAS NOTIFIED. NO FURTHER INFO HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 160NRE DIALYZER HEMODIALYSIS DIALYZER FJI OGDEN MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| O| R