BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.Y

    MDR report key: 2230655 · Received August 12, 2011

    Report

    Report Number
    1713747-2011-00036
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 18, 2011
    Report Date
    August 12, 2011
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPORTED A DIALYZER REACTION IN THE HOSPITAL TO THE 160NRE, A "FIRST USE" SYNDROME TO THE DIALYZER. THIS EVENT OCCURRED AS AN INPATIENT. AT APPROXIMATELY WITHIN MINUTES FROM THE START OF THE DIALYSIS TREATMENT, THE PT REPORTED NOT FEELING WELL. THE NURSE NOTED THAT THE BLOOD PRESSURE DROPPED TO 76/32. THE MD WAS NOTIFIED AND A 600 NORMAL SALINE BOLUS WAS GIVEN. CARDIAC ENZYMES WERE DRAWN PER MD ORDERS. THE RN RETURNED THE PT'S BLOOD AND DISCONTINUED THE DIALYSIS. THE PT NOW RECEIVES FURTHER DIALYSIS WITH USE OF THE GAMBRO DIALYZER 170H WITHOUT FURTHER INCIDENT. THERE IS NO SAMPLE AND THE LOT IS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| O| R