BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4222191 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38632
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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 IN. 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 THE CASSETTE TUBING HAD BEEN DAMAGED BY THE PATIENT¿S CAT, PRIOR TO THE HOME PATIENT CONNECTING FOR PERITONEAL DIALYSIS THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE HOME PATIENT IN ENDING THERAPY, REMOVING THE CASSETTE AND EXPLAINED WHY NEW SUPPLIES WERE NEEDED TO COMPLAINT THERAPY. THE HP WOULD COMPLETE THERAPY USING ALL NEW 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
    703056 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HOMECHOICE