BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENIUM XPH

    MDR report key: 3022641 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07360
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 5, 2013
    Manufacturer
    NIPRO CORPORATION *USD*
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. A RETAINED SAMPLE FROM THE SAME LOT WAS VISUALLY AND FUNCTIONALLY TESTED BY (B)(4) WITH NO DAMAGE OR LEAKS NOTED. A MANUFACTURING BATCH RECORD REVIEW WAS PERFORMED BY (B)(4) WITH NO ISSUES OR ABNORMALITIES NOTED DURING THE MANUFACTURE OF THIS LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS EVALUATED BY BAXTER. A VISUAL INSPECTION WAS PERFORMED AND THERE WAS SOME BLOOD LEAKING THROUGH THE HEADER CAP WHERE IT IS SCREWED ON AT THE DIALYZER. A LEAK TEST WAS PERFORMED AND AT VENOUS END THERE WERE BUBBLES INSIDE THE FIBERS WHICH WAS AIR BUBBLES. NO LEAKAGE WAS FOUND AT THE CONNECTION OF DIALYZER AND THE BLOODLINE. THE SAMPLE WAS NOT CONFIRMED FOR THE REPORTED PROBLEM AND THE ROOT CAUSE WAS UNDETERMINED. A RETAINED SAMPLE FROM THE SAME LOT WAS VISUALLY AND FUNCTIONALLY TESTED BY NIPRO WITH NO DAMAGE OR LEAKS NOTED. A MANUFACTURING BATCH RECORD REVIEW WAS PERFORMED BY NIPRO WITH NO ISSUES OR ABNORMALITIES NOTED DURING THE MANUFACTURE OF THIS LOT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED DIALYZER BY BAXTER PERSONNEL, IT WAS NOTICED THAT BUBBLES WERE COMING FROM THE VENOUS HEADER CAP AND IN THE FIBERS OF THE DIALYZER. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126959 XENIUM XPH DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* 12G19B

    Patients

    Seq Age Sex Outcome Treatment
    1