BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 4251034 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40583
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBER H14F26048 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. ONE UNOPENED COMPANION EXTENSION SET SAMPLE WAS RECEIVED. THE PRODUCT MET ALL VISUAL/FUNCTIONAL TESTING REQUIREMENTS. THE REPORTED EVENT WAS NOT VERIFIED/DUPLICATED DURING SAMPLE ANALYSIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN UNUSED DEVICE OF THE SAME LOT AS THE ACTUAL DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 12 FOOT EXTENSION SET LEAKED. THIS OCCURRED DURING AN UNSPECIFIED STEP OF PERITONEAL DIALYSIS SETUP OR THERAPY. PATIENT CONNECTION AT THE TIME OF THE INCIDENT IS UNKNOWN. THE SET WAS BEING USED AS A PATIENT LINE EXTENSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737190 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H14F26048

    Patients

    Seq Age Sex Outcome Treatment
    1