BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXELTRA 190 - SINGLE USE HIGHFLUX DIALYZER

    MDR report key: 1231647 · Received November 14, 2008

    Report

    Report Number
    1423500-2008-00916
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 23, 2008
    Manufacturer
    NIPRO CORP
    Product Code
    KDI
    PMA / PMN Number
    K030975
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE BAXTER PRODUCT ANALYSIS LAB REC'D ONE USED EXELTRA 190 DIALYZER. VISUAL INSPECTION OF THE DIALYZER FOUND NO OBVIOUS DEFECTS. A MANUAL LEAK TEST WAS PERFORMED AND HAD A DECAY OF 272 AND 280 MMHG IN 60 SECONDS. THE BUBBLE POINT LEAK TEST WAS PERFORMED AND HAD A DECAY OF 288 AND 288 MMHG IN 30 SECONDS. THERE WERE D IN BUBBLES, WHICH WERE SLOWLY COMING OUT OF THE VENOUS DIALYSATE PORT AT THE TEST STRIP ZONE. THE LEAKAGE OF FIBERS WAS CONFIRMED. NIPRO CORP IS PERFORMING A BATCH REVIEW OF THE REPORTED LOT NUMBER. A F/U REPORT WILL BE FILED UPON COMPLETION OF THE BATCH REVIEW OR IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IN 2008, BAXTER REC'D A REPORT OF BLOOD LEAK ON AN EXELTRA 190 DIALYZER. THIS IS THE SECOND BLOOD LEAK FOR THE SAME PT. IN THIS INCIDENT, THE PT COMPLAINED OF CHEST PAIN. THERE WAS A BLOOD LEAK ALARM. THE BLOOD LEAK WAS BELIEVED TO BE A FIBER LEAK AND WAS CONFIRMED WITH A HEMASTIX TEST. NO OTHER TYPES OF TEST STRIPS WERE USED. THE TEST STRIP WAS USED ON THE EFFLUENT POURED OUT OF THE SIDE OF THE DIALYZER. THE ESTIMATED BLOOD LOSS FOR THIS EVENT WAS NOT PROVIDED. THE DIALYZER WAS NOT REUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXELTRA 190 - SINGLE USE HIGHFLUX DIALYZER 78KDI KDI NIPRO CORP 08B04E

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening