BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 3930305 · Received July 11, 2014

    Report

    Report Number
    1416980-2014-22452
    Event Type
    Injury
    Date Received
    July 11, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBER H14D15087 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION. THE DEVICE WAS NOT RETURNED, THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS REPORT REFERENCES THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE THE PATIENT WAS TREATED WITH ¿UNKNOWN MEDICATION¿. THE CAUSE OF THE PERITONITIS WAS REPORTED TO BE A MISSING CAP FROM THE EXTENSION SET. THE MISSING CAP WAS NOT NOTICED UNTIL THE CAREGIVER WAS ¿ALMOST DONE HOOKING THE PATIENT UP TO THE HOMECHOICE DEVICE AND BEGINNING THERAPY¿. IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR ¿ONE DAY STAY¿. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406707 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H14C15087

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HOMECHOICE