BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3181585 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16111
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR SYSTEM ERROR 2240, WHERE THE HOME PATIENT HAD CUT THE HEATER BAG WHEN TRYING TO OPEN IT. 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 WARNS THE USER TO FOLLOW ASEPTIC TECHNIQUE TAUGHT BY YOUR DIALYSIS CENTER WHEN HANDLING LINES AND SOLUTION BAGS TO REDUCE THE POSSIBILITY OF INFECTION. IT ALSO WARNS THE USER THAT USING DAMAGED SETS CAN RESULT IN CONTAMINATION OF THE LUCID OR FLUID PATHWAYS. 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 DWELL 2 OF 4, WHILE THE HP WAS CONNECTED. THE HP HAD CUT THE TOP OF THE HEATER BAG WHEN OPENING IT. THE HP THOUGHT THAT IT WOULD BE STILL OKAY TO USE SINCE NO LEAKS WERE NOTICED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO THE HP THE PROPER PROCEDURES. THE HP WAS GOING TO FINISH THE THERAPY USING MANUAL SUPPLIES. 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
    282260 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE