BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4210637 · Received October 29, 2014

    Report

    Report Number
    1416980-2014-37896
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS, NO EVALUATION COULD BE PERFORMED. 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 REPLACE EMPTY SOLUTION BAGS OR RECONNECT DISCONNECTED SOLUTION BAGS DURING THERAPY. IT ALSO WARNS THE USER THAT POSSIBLE CONTAMINATION OF THE FLUID OR FLUID PATHWAYS CAN RESULT IF DISPOSABLES ARE REUSED. A 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 DURING THE TROUBLE SHOOTING OF AN UNRELATED ALARM THAT THE PATIENT HAD REUSED SINGLE USE DISPOSABLE SUPPLIES WHILE PERFORMING THERAPY ON THE HOMECHOICE DEVICE. THE HOME PATIENT (HP) WAS CONNECTED TO THE HOMECHOICE DURING LAST FILL. THE HP HAD DISCONNECTED THE EMPTY BAG AND RECONNECTED A NEW SOLUTION BAG. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED PROPER PROCEDURE TO THE CAREGIVER AND ASSISTED IN ENDING THERAPY. 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
    692727 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOMECHOICE