BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOODLINE FOR HEMODIALYSIS

    MDR report key: 2133842 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07841
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    November 21, 2008
    Report Date
    November 21, 2008
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS EVALUATED. THE CAUSE OF THE LEAK WAS DETERMINED TO BE EXCESS SOLVENT IN THE ASSEMBLY OF THE BUSHING OF THE ARTERIAL LINE TO THE MONITORING LINE. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THIS MDR IS BEING SUBMITTED AS PART OF BAXTER RENAL'S RETROSPECTIVE REVIEW & REMEDIATION PROJECT. THIS REPORT IS BEING FILED LATE TO FULFILL BAXTER'S COMMITMENT TO PERFORM A TWO YEAR RETROSPECTIVE REVIEW OF RENAL COMPLAINTS IN RESPONSE TO FDA-WARNING LETTER (B)(4).

    Description of Event or Problem · 1

    THE NURSE FROM (B)(6) REPORTED A DEVICE LEAK IN 1 UNIT DURING PRIME. THE THE DEVICE LEAKED IN THE TUBE WHERE THE HYDROPHOBIC FILTER IS PLACED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOODLINE FOR HEMODIALYSIS SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK BAXTER HEALTHCARE - CALI SE08JJ7

    Patients

    Seq Age Sex Outcome Treatment
    1