BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXELTRA PLUS 210 - SINGLE USEHIGH FLUX DIALYZER

    MDR report key: 1212364 · Received October 29, 2008

    Report

    Report Number
    1423500-2007-88858
    Event Type
    Death
    Date Received
    October 29, 2008
    Date of Event
    June 7, 2007
    Report Date
    June 11, 2007
    Manufacturer
    NIPRO CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K030975
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 10, 2007. BAXER INITIATED AN INVESTIGATION OF THE CUSTOMER REPORT. THE ACTUAL SAMPLE WAS DISCARDED BY THE FACILITY. BAXTER OFFERED A CUSTOMER VISIT IN 2007, BUT HAVE NOT BEEN ACCEPTED YET. THE MANUFACTURING FACILITY (NIPRO CORPORATION) HAS BEEN MADE AWARE OF THIS REPORT. IN 2007, THE INITIAL REPLY FROM NIPRO REVEALED; NO ABNORMALITIES WERE FOUND IN THE RECORDS AND FINDINGS OF THE BIOLOGICAL TESTS PERFORMED IN RELEASE INSPECTION OF THE LOTS CONCERNED, HOWEVER BIOLOGICAL TEST OF THE RETAINED SAMPLES WILL BE CONDUCTED AND THE RESULTS WILL BE PROVIDED UPON COMPLETION OF THE TEST. BAXTER IS MONITORING ISSUES LIKE THIS. IF ADDITIONAL INFORMATION IS DISCOVERED A FOLLOW UP REPORT WILL BE SUBMITTED.BLOOD LINES PRODUCT CODE: 003-410-510, LOT # 02N157300 OR 04N157300, MANUFACTURED BY GAMBRO, CODE C3 INSTRUMENT, MANUFACTURED BY GAMBRO.

    Description of Event or Problem · 1

    THE DIRECTOR OF DIALYSIS SERVICES AT OUTPATIENT DIALYSIS UNIT REPORTED TO BAXTER PRODUCT SURVEILLANCE THAT, A PATIENT DEVELOPED SYMPTOMS OF HEMOLYSIS DURING A REGULAR HEMODIALYSIS TREATMENT. REPORTEDLY, THREE HOURS INTO THE DIALYSIS TREATMENT THE PATIENT STARTED COMPLAINING ABDOMINAL PAIN AND CHEST PAIN. THE TREATMENT WAS TERMINATED AND THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AT THE HOSPITAL. AT THE HOSPITAL THE MAJOR COMPLAINT OF THE PATIENT WAS ABDOMINAL PAIN AND NAUSEA. THE PHYSICIAN RULED OUT A RUPTURED AORTIC ANEURISM, BUT THE CLINICAL APPLICATION PROVIDED WAS A MAJOR HEMOLYTIC REACTION. THE PATIENT¿S HEMOGLOBIN LEVEL AFTER THE EVENT TREATMENT DROPPED TO 8G/DL. THE WEEK BEFORE, THE HEMOGLOBIN VALUE WAS 12.6G/DL. THE PATIENT CONDITION WAS SERIOUS. SINCE A SEVERE DROP IN THE HEMOGLOBIN WAS NOTED AND THE ANEMIA CONFIRMED, FOUR UNITS OF BLOOD WAS GIVEN TO THE PATIENT. THE PATIENT WAS PLACED ON DOPAMINE AND DOBUTAMINE TO KEEP HIS BLOOD PRESSURE STABLE. ADDITIONAL INFORMATION PROVIDED BY THE DIRECTOR OF DIALYSIS SERVICES ON THE NEXT DAY INDICATED THAT THIS PATIENT DIED IN ICU AT MEDICAL CENTER ON THE EVENING OF 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXELTRA PLUS 210 - SINGLE USEHIGH FLUX DIALYZER 78KDI KDI NIPRO CORPORATION 07C01D

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| H| L| R FLAGYL 500MG TID FOR TWO MONTHS STARTED ON| CEPHALEXIN 250MG FOR 10 DAY'S STARTED ON| ZITROMAX STARTED ON