BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 2230640 · Received August 12, 2011

    Report

    Report Number
    1713747-2011-00037
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 16, 2011
    Report Date
    August 12, 2011
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    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 DIALYSIS FACILITY REPORTED A "FIRST USE" SYNDROME TO THE DIALYZER. THE FACILITY HAS BEEN CONTACTED FOR FURTHER DETAIL REGARDING THE EVENT. IT WAS LEARNED THAT THE PT STARTED DIALYSIS WHEN APPROXIMATELY AFTER A FEW MINUTES INTO DIALYSIS THE BLOOD PRESSURE DROPPED TO 85/48. THE PT WAS GIVEN 500 ML OF NORMAL SALINE AND THEY CONTINUED TO MONITOR THE PT. THE BLOOD PRESSURE DROPPED AGAIN AND ANOTHER BOLUS OF 600 ML OF NORMAL SALINE WAS GIVEN AND THE ULTRA FILTRATION WAS TURNED OFF. THE DIALYSIS TREATMENT ENDED WITHOUT FURTHER INCIDENT AND THE BLOOD WAS RETURNED. THE PT WAS DISCHARGED TO HOME WITHOUT FURTHER INCIDENT. THERE IS NO SAMPLE. OF NOTE: IT WAS REPORTED THAT THE PT HAD BEEN RECEIVING DIALYSIS WITH USE OF THIS PRODUCT FOR APPROXIMATELY ONE YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER FJI OGDEN MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other