BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 4860257 · Received June 22, 2015

    Report

    Report Number
    1416980-2015-26172
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 11, 2015
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND IDENTIFIED NO ISSUES. FUNCTIONAL TESTING OF THE DEVICE INCLUDED LEAK TESTING, CLEAR PASSAGE TESTING AND PRESSURE TESTING; FUNCTIONAL TESTING IDENTIFIED NO ISSUES WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS CONDITION DURING THE MANUFACTURE OF THIS LOT. THE REPORTED ISSUE WAS NOT VERIFIED, AND THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DISCOVERED A LEAKING EXTENSION SET. THIS OCCURRED DURING PRIMING OF PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS NOT CONNECTED AT THE TIME OF THE EVENT. THE PATIENT STATED THAT THE LEAK WAS NOTICED "FROM THE END OF THE EXTENSION SET THAT HAS THE CAP ON IT." THE PATIENT CONFIRMED THAT IT WAS LEAKING FROM THE END THAT THEY WOULD NORMALLY CONNECT TO THEIR TRANSFER SET. THE PATIENT STATED THERE WAS NO NOTICEABLE DAMAGE TO THE PRODUCT OR OVERPOUCH. THE PATIENT STATED THEY WERE ABLE TO COMPLETE THERAPY BY STARTING OVER WITH ALL NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404424 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H15C21045

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR