BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY

    MDR report key: 3040274 · Received April 3, 2013

    Report

    Report Number
    1713747-2013-00079
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 5, 2013
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPEC.

    Description of Event or Problem · 1

    A HEMODIALYSIS PT EDUCATOR HAS REPORTED THAT DURING TREATMENT, A BLOOD LEAK OCCURRED. PT WAS ON TRAINING FOR HOME HEMO. PT EDUCATOR NOTICED BLOOD DROPS ON THE FLOOR UNDER THE DIALYZER AND THE LIP OF THE DIALYZER HAD BLOOD ON IT. THE DIALYZER APPEARED TO BE LEAKING FROM VENOUS END RIM. ALL THE CONNECTIONS WERE TIGHT AND NO ALARMS OCCURRED. PT HAD 22 MINUTES LEFT IN TREATMENT. PT TAKEN OFF TREATMENT, GIVEN ANTIBIOTICS AND LOST APPROX 20 ML BLOOD. PT HAD NO ILL EFFECTS. SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136423 OPTIFLUX 160NRE DIALYZER FINISHED ASSY HEMODIALYSIS DIAYZER KDI OGDEN MANUFACTURING 12NU01008

    Patients

    Seq Age Sex Outcome Treatment
    1