BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY

    MDR report key: 4844442 · Received June 12, 2015

    Report

    Report Number
    1713747-2015-00280
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 27, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PLANT'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A VISUAL INSPECTION OF THE DEVICE WAS PERFORMED AND REVEALED DEBRIS LODGED BETWEEN THE SILICONE O-RING AND POLYURETHANE CUT SURFACE. THE DEBRIS CAUSED A CHANNEL IN THE SEALING SURFACE AND INTO THE POLYCARBONATE THREADS. VISUAL CHARACTERISTICS OF THE DEBRIS ARE CONSISTENT WITH POLYURETHANE/POLYETHYLENE SLIVERS. THE DEVICE WAS SUBJECTED TO A LABORATORY EXTERNAL LEAK TEST WHERE THE DIALYZER WAS SUBMERGED AND PRESSURIZED INCREMENTALLY, AND NO LEAK WAS DETECTED. THIS WAS DUE TO COAGULATED BLOOD NOTED BETWEEN THE SCREW FLANGE AND THE DIALYZER HOUSING THREADS. THE COMPLAINT WAS CONFIRMED AND IS A KNOWN FAILURE TYPE ASSOCIATED WITH THE PRODUCT. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS INPATIENT USER FACILITY REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED BETWEEN THE FIRST AND SECOND HOUR OF THERAPY. THE LEAK WAS VISUALLY OBSERVED AT THE VENOUS END OF THE DIALYZER. THE MACHINE DID NOT ALARM. BLOOD TEST STRIPS WERE NOT USED. THE ESTIMATED PT BLOOD LOSS WAS 10 CC. THE PT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PT COMPLETED HIS TREATMENT ON A DIFFERENT MACHINE IN THE FACILITY WITH A NEW SET-UP. THE SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384214 OPTIFLUX 180NRE DIALYZER FINISHED ASSY FJI FRESENIUS MEDICAL CARE NORTH AMERICA 15BU02015

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR