BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3182052 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-15938
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY DISCONNECTING DURING EMERGENCIES AND FOR RETURNING TO THERAPY AFTER THE EMERGENCY DISCONNECT PROCEDURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERITONEAL DIALYSIS (PD) THERAPY, A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) AND SUBSEQUENT SE 2367 (FAIL SAFE SHUTDOWN) OCCURRED ON THE HOMECHOICE (HC) MACHINE DURING DWELL. THE TSR EXPLAINED THE ALARMS. THE HP DISCONNECTED IN DWELL AND THE HC WENT INTO DRAIN. THE HP DID NOT PRESS STOP. THE HP RECONNECTED. THE TSR EXPLAINED PROPER DISCONNECT PROCEDURES AND ASSISTED TO RETRIEVE THE CASSETTE. THE TSR ADVISED THE HP TO LET HER REGISTERED NURSE KNOW ABOUT THE ALARM. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283546 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOMECHOICE