BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA-HP

    MDR report key: 2133796 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07838
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    December 21, 2009
    Report Date
    January 19, 2010
    Manufacturer
    NIPRO CORPORATION USD
    Product Code
    MSF
    PMA / PMN Number
    K970653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE ROOT CAUSE IS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE 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. 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 CHI-07-10.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT SEVEN UNITS OF BLOOD LEAKED DURING PATIENT USE BETWEEN THE SECOND AND THIRD USES OF THE DEVICE. A LEAK ALARM OCCURRED FIRST AND THEN IT WAS NOTED THAT BLOOD WAS LEAKING OUT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CA-HP HEMODIALYZER, RE-USE, HIGH FLUX MSF NIPRO CORPORATION USD 09G18C

    Patients

    Seq Age Sex Outcome Treatment
    1 HD HARDWARE