BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 3161704 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-14922
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR A SYSTEM ERROR 2240, WHERE THE HP STATED THAT THE PATIENT LINE EXTENSION HAD DISCONNECTED FROM THE TRANSFER SET DUE TO NOT BEING SECURED TIGHTLY ENOUGH. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN "THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE," WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. IT INSTRUCTS THE USER TO CHECK ALL DISPOSABLE SET CONNECTIONS FOR A SECURE FIT BEFORE BEGINNING THERAPY. ALSO, IT PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY CONNECTING THE PATIENT LINE TO THE TRANSFER SET. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ANY RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN TUBING) ON THE HOMECHOICE (HC) DURING THE INITIAL DRAIN WHILE THE HP WAS CONNECTED. THE HP STATED THAT THE PATIENT LINE EXTENSION HAD DISCONNECTED FROM THE TRANSFER SET DUE TO NOT BEING SECURED TIGHTLY ENOUGH. THE HP DISCONNECTED FROM THE HC AND CAPPED OFF THE LINES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH CLEARING THE ALARM SO THAT THE HP COULD SET UP THE HC USING ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262212 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE| HOMECHOICE