BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 2230639 · Received August 12, 2011

    Report

    Report Number
    1713747-2011-00035
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 14, 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 REPORT HAS BEEN RECEIVED FROM A DIALYSIS FACILITY REPORTING A "FIRST USE" SYNDROME TO THE DIALYZER. FOR THIS EVENT THE PT STARTED DIALYSIS WHEN APPROXIMATELY AT 15 MINUTES INTO THE TREATMENT, THE SYMPTOMS WERE NAUSEA, SWEATING PROFUSELY AND A LOW BLOOD PRESSURE OF 90/65. A SALINE BOLUS WAS GIVEN. REPORTEDLY THE PT WAS FEELING BETTER WHEN AT APPROXIMATELY AGAIN AT ONE HOUR INTO DIALYSIS THE PT BECOME UNCONSCIOUS AND ANOTHER SALINE BOLUS WAS GIVEN. THEN WITHIN 15 MINUTES, THE PT'S BLOOD PRESSURE DROPPED AGAIN AND HE HAD ANOTHER DECREASED LEVEL OF CONSCIOUSNESS AT THIS TIME, ANOTHER SALINE BOLUS WAS GIVEN. THE PT THEN BECAME DIAPHORETIC AND VOMITED. THE MD WAS NOTIFIED OF THE EVENT. THE PT RECOVERED AND COMPLETED THIS TREATMENT AND WAS DISCHARGED TO HIS HOME. THE TOTAL AMOUNT OF SALINE GIVEN WAS APPROXIMATELY 700 ML. THE PT NOW CONTINUES DIALYSIS WITH USE OF THE GAMBRO DIALYZER 170H 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| R