BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3854265 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18230
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF A USE ERROR, WHERE THE CAREGIVER STATED THAT THE DOG HAD CHEWED THROUGH 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. THE GUIDE WARNS THE USER NOT TO PERFORM DIALYSIS IN THE SAME ROOM WHERE PETS OR ANIMALS ARE. IT STATES THAT ¿CONTAMINATION OF THE FLUID OR FLUID PATHWAYS CAN RESULT IF A PET OR ANIMAL BITES A SOLUTION BAG OR THE DISPOSABLE SET. CONTAMINATION OF ANY PORTION OF THE FLUID OR FLUID PATH MAY RESULT IN PERITONITIS, SERIOUS PATIENT INJURY, OR DEATH.¿ A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DOG CHEWED THROUGH THE PATIENT LINE OF A HOMECHOICE AUTOMATED PD SET WITH CASSETTE. THIS OCCURRED DURING DWELL CYCLE ONE OF PERITONEAL DIALYSIS THERAPY. THE HOME PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. THE CAREGIVER STATED THAT ¿THE DOG CAME INTO THE ROOM AND CHEWED THROUGH THE PATIENT LINE.¿ THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CAREGIVER IN ENDING THERAPY AND ADVISED THE CAREGIVER TO CONTACT THE REGISTERED NURSE REGARDING THE INCIDENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333105 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR HOMECHOICE