BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 1983926 · Received February 4, 2011

    Report

    Report Number
    1713747-2011-00003
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    December 9, 2010
    Report Date
    February 4, 2011
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED OF A SUSPECTED ALLERGIC OR HYPERSENSITIVITY REACTION REPORT. THE RN REPORTED THAT THE EVENT OCCURRED DURING DIALYSIS. INITIALLY REPORTED WAS THAT THE PT WAS BRAND NEW TO DIALYSIS AND THAT SHE HAD A BLOOD PRESSURE DROP WITH LOSS OF CONSCIOUSNESS. ADDITIONAL SYMPTOMS REPORTED WERE CHEST PAIN AND SHORTNESS OF BREATH. THE FACILITY FLUSHED WITH NORMAL SALINE AND RETURNED THE PT'S BLOOD. THE TREATMENT WAS LATER RESUMED. AS A RESULT OF THIS EVENT, THE MD BELIEVES THIS EVENT IS A DIALYZER REACTION. THEY HAVE NOW CHANGED THE DIALYZER TO A DIFFERENT MANUFACTURED BRAND. CURRENTLY, THE PT IS FINE. THERE IS NO SAMPLE AND THE LOT IS UNK. OF NOTE: IN REVIEW OF THIS FILE AND THE INFO RECEIVED, IT WAS DETERMINED THAT THE PT TOLERATED THIS DIALYZER AS EVIDENCED IN THE TREATMENT RECORD. THIS EVENT WAS THE FIRST DIALYSIS TREATMENT THAT THE PT RECEIVED IN THIS UNIT. FOR THIS EVENT THE PT STARTED DIALYSIS WHEN THE BLOOD FLOW RATE WAS INCREASED AND THEN THE BLOOD PRESSURE DROPPED AND THE PT THEN HAD A BRIEF EPISODE OF UNRESPONSIVENESS. THIS PT WAS GIVEN OXYGEN AND A NORMAL SALINE BOLUS. THE BLOOD PRESSURE IMPROVED AND THE PT BECAME RESPONSIVE. THIS INCIDENT DID NOT REQUIRE ANY TRANSFER TO THE HOSPITAL OR MEDICAL INTERVENTION. THE PT REMAINED ON THIS DIALYZER FOR REMAINDER OF THIS DIALYSIS TREATMENT. IT WAS ALSO NOTED THAT THE PT RECEIVED DIALYSIS WITH USE OF THIS DIALYZER HOWEVER, HAS SINCE BEEN ORDERED A NEW PRESCRIPTION FOR THE DIALYZER. ADDITIONALLY, THE MD HAD NOTED THAT THEY WILL DECREASE THE WEIGHT AS TOLERATED. IT WAS NOTED THEY WERE "PULLING FLUID" FOR THIS TREATMENT.

    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 68 YR Other