BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3834565 · Received May 28, 2014

    Report

    Report Number
    1416980-2014-17154
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THIS COMPLAINT IS FOR A REPORT OF A DAMAGED PATIENT DURING USE WHERE THE NURSE STATED THE PATIENT LINE WAS PUNCTURED WHEN ATTEMPTING TO ADMINISTER MEDICATION IN THE MEDICATION PORT. 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. SECTION ¿PREPARE FOR THERAPY¿ WARNS THE USER TO FOLLOW ASEPTIC TECHNIQUE TAUGHT BY YOUR DIALYSIS CENTER WHEN HANDLING LINES AND SOLUTION BAGS TO REDUCE THE POSSIBILITY OF INFECTION. SECTION ¿PREPARE FOR THERAPY¿ AND ¿QUICK REFERENCE¿ WARN THE USER THAT USING DAMAGED SETS CAN RESULT IN CONTAMINATION OF THE FLUID OR FLUID PATHWAYS. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT LINE WAS DAMAGED DURING USE ON THE HOME CHOICE (HC). THE REGISTERED NURSE (RN) INDICATED THAT THE PATIENT LINE WAS PUNCTURED WHEN ADDING MEDICATION TO THE PORT. THE RN INDICATED IT WAS DUE TO POOR AIMING AND THE NEEDLE WHEN THROUGH THE SIDE OF THE MEDICATION PORT AND PUNCTURED THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE RN TO REPLACE THE ENTIRE SET UP. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313896 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR HOMECHOICE