BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 2139339 · Received June 20, 2011

    Report

    Report Number
    1713747-2011-00019
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    February 12, 2011
    Report Date
    June 20, 2011
    Manufacturer
    OGEDN 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

    AN INITIAL REPORT RECEIVED STATED THAT THE PATIENT HAD REACTION DURING TREATMENT. MULTIPLE ATTEMPTS WERE MADE IN ORDER TO OBTAIN ADDITIONAL INFORMATION. ON (B)(6) 2011, THE FOLLOWING INFORMATION WAS RECEIVED: PATIENT IS A (B)(6) YEAR OLD FEMALE WHO IS DIALYZED VIA A RIGHT INTERNAL JUGULAR PERMACATH PRESENTED TO OUTPATIENT DIALYSIS ON (B)(6) 2011, TWO MINUTES INTO HEMODIALYSIS TREATMENT BECAME UNCONSCIOUS AND SUBSEQUENTLY HAD A CARDIORESPIRATORY ARREST. CPR WAS INITIATED AND THE PATIENT WAS RESUSCITATED AND ADMITTED TO THE HOSPITAL. PATIENT HAD BEEN REPORTED TO BE WEAK, HAD TAKEN VICODIN FOR PAIN AND WAS FALLING AT HOME AND WAS UNABLE TO WALK PRIOR TO HD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| O