BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4780532 · Received May 19, 2015

    Report

    Report Number
    1416980-2015-21922
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    May 3, 2015
    Report Date
    May 3, 2015
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) . NOT FOLLOWING PROPER DISCONNECTION OR RECONNECTION PROCEDURES IS A KNOWN CAUSE OF THIS ALARM. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO SYSTEMS PATIENT AT-HOME GUIDE¿, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY DISCONNECTING DURING EMERGENCIES. ALSO, IT PROVIDES STEP-BY-STEP INSTRUCTIONS FOR RETURNING TO THERAPY AFTER THE EMERGENCY DISCONNECT PROCEDURE. 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 HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DRAIN FOUR OF FOUR OF PERITONEAL DIALYSIS THERAPY. THE PATIENT STATED THERE WERE AIR BUBBLES IN ALL OF THE LINES EXCEPT FOR THE HEATER LINE. DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT THE PATIENT DISCONNECTED PROPERLY DURING DWELL AND IMPROPERLY RECONNECTED DURING DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE REVIEWED PROPER PROCEDURES WITH THE PATIENT. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE PATIENT WITH ENDING THERAPY AND REMOVING THE CASSETTE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325891 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE