BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 3082478 · Received April 25, 2013

    Report

    Report Number
    1713747-2013-00097
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    OGDEN MFG
    Product Code
    KDI
    PMA / PMN Number
    K002761
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS WERE REQUESTED AND HAVE NOT BEEN RECEIVED BY THE MFR TO DATE. AT THE CONCLUSION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE RESULTS OF THE CLINICAL AND PLANT INVESTIGATIONS.

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 150CC'S. THE PT'S BLOOD PRESSURE DROPPED AND SHE BECAME UNRESPONSIVE (BP'S HAVE NOT BEEN PROVIDED TO DATE). THE PT WAS TRANSFERRED TO THE ICU AND THE NURSE VERBALLY REPORTED THE PT IS DOING WELL NOW. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179749 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. HEMODIALYSIS DIALYZER KDI OGDEN MFG 13BU06006

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| O| R FRESENIUS 2008 K MACHINE