BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U0308 XENIUM 210G SYNTH HFDIALYZER

    MDR report key: 1251697 · Received December 2, 2008

    Report

    Report Number
    1423500-2008-00956
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 15, 2008
    Report Date
    November 18, 2008
    Manufacturer
    NIPRO CORP
    Product Code
    KDI
    PMA / PMN Number
    K062079
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE SAMPLE HAS BEEN MADE. SHOULD THE SAMPLE BE RECEIVED FOR EVAL, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVAL OR IF ANY ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE ANTRIM AREA HOSP REPORTED HEMOLYSIS OCCURRED AFTER A PT RECEIVED HEMODIALYSIS USING A BAXTER XENIUM 210 DIALYZER IN 2008. A GAMBRO AK200 AND GAMBRO BLOODLINES BL225, LOT NUMBER 0850 WERE ALSO IN USE. THE ACID CONCENTRATE WAS BAXTER PRODUCT AND GAMBRO BICARBONATE CONCENTRATE WERE USED. THE PT WAS ON HEMODIALYSIS APPROX 20 MINUTES WHEN HE BECAME UNWELL, ANXIOUS, WITH PRESSURE SENSATION IN HEAD; EARS POPPING, SHIVERS, DECREASED TEMPERATURE AND ABDOMINAL PAIN (LOWER GROIN). A BLOOD PRESSURE OF 200/114 WAS MEASURED. THE SESSION WAS STOPPED AND THE SYMPTOMS RESOLVED AFTER FIVE MINUTES. THE PT'S BLOOD SAMPLES SHOWED EVIDENCE OF HEMOLYSIS. THE PT HAS BEEN USING A XENIUM DIALYZER FOR THREE WEEKS AND HAD NEVER EXPERIENCED A REACTION. THE DIALYZER WAS USED AS A DRY PACK (NOT REUSED). THE VASCULAR ACCESS WAS AN ARTERIO-VENOUS FISTULA PUNCTURED WITH A BAXTER SEOFLO FISTULA NEEDLE. THE PROGRAMMED ANTICOAGULATION WAS A BOLUS OF 1000 IU LITHIUM HEPARIN AT THE START OF THE DIALYSIS SESSION FOLLOWED BY 500 IU/HOUR. THE LINES WERE PRIMED WITH ONE LITER OF SALINE SOLUTION (MFR'S NAME, PRODUCT CODE AND LOT NUMBER UNK). THE THERAPY WAS PROGRAMMED FOR FOUR HOURS WITH A BLOOD FLOW RATE OF 390 ML/MIN AND AN ULTRA FILTRATION (UF) GOAL OF 0.7 LITERS. THE DIALYSIS SESSION STARTED AT 7:20 AM. NO UNTOWARD MACHINE ALARMS WERE REGISTERED DURING THE TREATMENT. NO LEAK WAS NOTICED DURING THE TREATMENT AND NO BLOOD LOSS HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U0308 XENIUM 210G SYNTH HFDIALYZER 78KDI KDI NIPRO CORP 08F05S

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention PLATELETS COUNT DROPS TOO LOW| AZATHIOPRINE 150 MG FOR TWO DAYS WHEN HIS