BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY

    MDR report key: 3820626 · Received May 1, 2014

    Report

    Report Number
    1713747-2014-00225
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, IT IS UNKNOWN HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET CLINICAL DEPARTMENT IS IN THE PROCESS OF REQUESTING PT MEDICAL RECORDS AND TREATMENT DATA INFO REGARDING THE REPORTED PT REACTION. A SUPPLEMENT MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A CLINIC REGISTERED NURSE (RN) REPORTED A PT WHO REPORTED FEELING TIGHTNESS IN HER THROAT, SHORTNESS OF BREATH, AND NAUSEA A FEW MINUTES INTO HER FIRST HEMODIALYSIS TREATMENT. THE PT RECEIVED IV ANTIHISTAMINE AND OXYGEN. THE DIALYZER WAS DISCARDED AND A NEW F160 NRE DIALYZER WAS SET UP FROM THE SAME LOT AND THE SYMPTOMS RECURRED. THIS DIALYZER WAS ALSO DISCARDED. A SECOND DOSE OF IV ANTIHISTAMINE WAS GIVEN. THE PT HAS BEEN CHANGED TO A DIFFERENT DIALYZER AND HAS NO FURTHER SYMPTOMS. SHE WAS NOT HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262402 OPTIFLUX 160NRE DIALYZER FINISHED ASSY FJI FRESENIUS MEDICAL CARE NORTH AMERICA 13PU01015

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention FRESENIUS ACID| FRESENIUS SALINE| FRESENIUS BLOODLINE| FRESENIUS DIALYSIS MACHINE| FRESENIUS BICARB