BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3953843 · Received July 23, 2014

    Report

    Report Number
    1416980-2014-23961
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. HOWEVER, ANIMAL DAMAGE WAS REPORTED AND IS KNOWN TO BE ABLE TO CAUSE THE REPORTED ISSUE. 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 THAT CONTAMINATION OF THE FLUID OR FLUID PATHWAYS CAN RESULT IF A PET OR ANIMAL BITES A SOLUTION BAG OR THE DISPOSABLE SET. THE GUIDE INSTRUCTS, IN ORDER TO REDUCE THIS RISK, THE PATIENT SHOULD NOT PERFORM DIALYSIS IN THE SAME ROOM AS PETS OR ANIMALS. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR 2240 (AIR IN SET) ALARM OCCURRED ON A HOME CHOICE (HC) DEVICE DURING DRAIN TWO OF FOUR. THE PATIENT WAS CONNECTED TO THE HOMECHOICE AT THE TIME OF THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THE ALARM AND ASSISTED THE PATIENT IN CLEARING THE ALARM. DURING THE TROUBLESHOOTING, IT WAS DETERMINED THAT THE PATIENT¿S DOG ¿NICKED¿ THE PATIENT LINE AND THE PATIENT HAD TAPED IT UP. THE PATIENT WAS TO CONTINUE THERAPY WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431996 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR HOMECHOICE