BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3081036 · Received April 26, 2013

    Report

    Report Number
    1416980-2013-10528
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORTED CONDITION. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE REPORTED LEAK WAS DETERMINED TO BE A USE ERROR, CAUSED BY THE PATIENT DISCONNECTING DURING THERAPY. THE INSTRUCTIONS IN THE HOMECHOICE PATIENT AT HOME GUIDE ARE SUFFICIENT AND RELEVANT FOR THIS ISSUE. THE HOMECHOICE PATIENT AT HOME GUIDE IS INCLUDED AND SHIPPED WITH EVERY CYCLER UNIT, AND THE INSTRUCTIONS ARE CLEARLY STATED. THE HOMECHOICE PATIENT AT HOME GUIDE STATES IN SECTION 15.10 (EMERGENCY DISCONNECT PROCEDURE) THE STEPS TO PROPERLY DISCONNECT FROM CYCLER DURING AN EMERGENCY. SECTION 15.10.2 GIVES INSTRUCTIONS ON HOW TO RECONNECT TO THERAPY. BOTH SECTIONS HAVE DIRECTIONS TO MAINTAIN ASEPTIC TECHNIQUE WHEN FOLLOWING TROUBLESHOOTING. THE EVENT DESCRIPTION STATED THAT THE USER DISCONNECTED A FROM THERAPY BEFORE ENDING THERAPY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REPORTING A HOME PATIENT (HP) DISCONNECTING FROM THE PATIENT LINE DURING DWELL 4 OF 5 ON THE HOMECHOICE (HC). THE HP WAS DISORIENTED AND DISCONNECTED DURING THERAPY. THE HP DID NOT CLOSE THE PATIENT LINE. AS A RESULT, BED AND CARPET WERE SOAKED. THE TSR ASSISTED TO END THE THERAPY. ACCORDING TO THE CARE GIVER (CG), THE CG WAS TAKING THE HP TO THE EMERGENCY ROOM. THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182875 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR HOMECHOICE