BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3182020 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-15936
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR WHEN AND HOW TO CONNECT TO THE DISPOSABLE SET. THE PREPARE FOR THERAPY SECTION, INSTRUCTS THE USER TO CONNECT THE TRANSFER SET TO THE PATIENT LINE AND TO OPEN THE TRANSFER SET, PRIOR TO STARTING THE INITIAL DRAIN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HOME PATIENT (HP) MADE A USE ERROR WHILE PERFORMING PERITONEAL DIALYSIS (PD) THERAPY. UPON INITIATING PD THERAPY WITH THE HOMECHOICE DEVICE (HC), THE HP ACCIDENTALLY FORGOT TO OPEN HER TRANSFER SET AND THE HC DEVICE ADVANCED TO FILL 1. THE HP STOPPED FILL RIGHT AWAY AND CALLED BAXTER TECHNICAL SERVICE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO GET TO MANUAL DRAIN TO ENSURE SHE DRAINED OUT EVERYTHING FIRST. THE HP UNDERSTOOD AND RESUMED WITH THERAPY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281951 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HOMECHOICE