BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX F18NRE DIALYZER FINISHED ASSY

    MDR report key: 3242870 · Received July 19, 2013

    Report

    Report Number
    1713747-2013-00269
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    OGDEN MFG.
    Product Code
    FJI
    PMA / PMN Number
    K043244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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 MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. AFTER MULTIPLE ATTEMPTS, THERE HAS BEEN NO FURTHER INFO PROVIDED AS TO THE AMOUNT OF BLOOD LOSS TO THE PT FROM THE INITIAL REPORTER. THERE IS NO INDICATION THAT THERE WAS ANY SERIOUS INJURIES TO THE PT BUT INSUFFICIENT INFO CANNOT RULE OUT THE POSSIBILITY AT THIS TIME, THEREFORE, A SERIOUS INJURY AND MALFUNCTION MDR WILL BE FILED. IF FURTHER INFO BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE MACHINE ALARMED WITH A BLOOD LEAK. THE ESTIMATED BLOOD LOSS IS UNK. SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338046 OPTIFLUX F18NRE DIALYZER FINISHED ASSY FJI OGDEN MFG. 13AU02017

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R HEMODIALYSIS MACHINE