BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENIUM

    MDR report key: 2181124 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09821
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 2011
    Manufacturer
    NIPRO CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K083778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THIS COMPLAINT COULD NOT BE CONFIRMED FOR HEMOLYSIS. THE ROOT CAUSE WAS UNDETERMINED. THE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. DURING TESTING, THE LAB FOUND THAT THERE WERE A FEW FIBERS THAT REMAINED WHITE DURING THERAPY SIMULATION. THE COMPLAINT INDICATES THAT "THE REPORTER STATED THAT A VISUAL ESTIMATION CONCLUDED THAT 1/3 OF THE DIALYZER WAS RED AND 2/3 WHITE." THIS WAS NOT CONFIRMED DURING LAB TESTING. NIPRO PERFORMED TESTING ON THE RETAINED SAMPLES FOR LOT NUMBER 10K11P FOR THE XENIUM 190. A REVIEW OF THE MANUFACTURING, PROCESS INSPECTION AND RELEASE INSPECTION RECORDS WAS PERFORMED AND NO DEFECTS WERE NOTED. IN ADDITION, TESTING OF THE RETAINED SAMPLES WAS PERFORMED. THE TESTING PERFORMED ON THE RETAINED SAMPLE INCLUDED HEMOLYSIS TESTING. NO ISSUES WERE FOUND IN RELATION TO HEMOLYSIS AT THE COMPLETION OF THE TESTING. NO OTHER ABNORMALITIES WERE IDENTIFIED DURING THE EVALUATION OF THE RETAINED SAMPLE. A TREND REVIEW WAS PERFORMED AND NO ADVERSE TREND WAS ASSOCIATED WITH HEMOLYSIS AND NIPRO'S CELLULOSIC AND SYNTHETIC FIBERED DIALYZERS. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4) - THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION. WHEN THE DEVICE IS RECEIVED AND/ OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A NEPHROLOGIST REPORTED TO BAXTER (B)(4) THAT A PATIENT EXPERIENCED HEMOLYSIS DURING HEMODIALYSIS (HD) THERAPY USING A BAXTER DIALYZER. THE REPORTER STATED THAT THERAPY STARTED AT 07:30 (B)(6) 2011. FORTY FIVE MINUTES AFTER THERAPY STARTED AT 08:15, THE REPORTER WAS ADVISED THAT THE DIALYZER WAS NOT PRESENTING THE USUAL RED COLOR. HE NOTED THAT THE RED CAP OF THE DIALYZER WAS PULSATING DUE TO THE PUMP MOVEMENT, EVIDENCE OF HYPER-PRESSURE IN THE DIALYZER. HE VISUALLY ESTIMATED THAT 1/3 OF THE DIALYZER WAS RED AND 2/3 WHITE AND WAS PARTIALLY DRY. THE TRANS-MEMBRANE PRESSURE WAS (B)(6). NO BLOOD LEAK ALARM DISPLAYED. THE EXTRACORPOREAL CIRCULATION WAS IMMEDIATELY RESTORED. THE HD THERAPY CIRCUIT MACHINE, LINE, AND DIALYZER WERE CHANGED. NO ABNORMALITIES WERE OBSERVED. THE PATIENT WAS ABLE TO FINISH THERAPY. REPORTEDLY, ANALYSIS PERFORMED PRIOR THE THERAPY INCLUDED AN IONOGRAM THAT SHOWED NO SIGNS OF HEMOLYSIS, ALTHOUGH THE COAGULATION TUBE WAS HEMOLYZED. THE REPORTER STATED THIS HD THERAPY UTILIZED AN INNOVA GENERATOR WHICH DOES NOT INCLUDE PRESSURE SENSORS BETWEEN THE DIALYZER AND BLOOD PUMP. CONSEQUENTLY, THE PATIENT WAS LATER HOSPITALIZED DUE TO THE HEMOLYSIS. THE PATIENT WAS STILL HOSPITALIZED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENIUM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION 10K11P

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization