BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3942518 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-23105
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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 THE DRAIN STAGE, WHERE THE HOME PATIENT RAN OVER THE PATIENT LINE AN CUT OFF THE PATIENT LINE. 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¿ WARNS 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 THE PATIENT LINE WAS SEVERED DURING DRAIN TWO OF FOUR ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) STATED THEY HAD RUN OVER THE PATIENT LINE WITH THEIR WHEELCHAIR. THE HP STATED THEY HAD CLOSED THE CLAMPS AND CAPPED OFF THE PATIENT LINE. THE HP STATED THEY WOULD START THERAPY OVER. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY. 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
    418279 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR HOMECHOICE