BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2982369 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04888
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WILL NOT BE CONDUCTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) IS CONFIRMED BECAUSE IT WAS REPORTED THAT PATIENT DISCONNECTED HIMSELF FROM DISPOSABLE SET; LINE DISCONNECTION (WITHOUT PROPER EMERGENCY DISCONNECT PROCEDURE) DURING THERAPY IS A KNOWN CAUSE OF SE 2240 ALARM. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE AND RELATED DIRECTION SHEET. BAXTER TRAINING MANUAL AND LABELING PROVIDE INSTRUCTIONS RELATED TO PREVENTION OF THESE USE ERRORS. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN SET) ON THE HOME CHOICE (HC). THE CAREGIVER (CG) STATED THE HOME PATIENT (HP) WAS DISCONNECTED FROM THE MACHINE AND THEY WERE JUST TRYING TO END THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND INSTRUCTED THE CG TO CYCLE THE POWER TO CLEAR THE ALARMS THEN REVIEWED THE ALARM LOG. THE HP HAD A SYSTEM ERROR 2240 PRIOR TO THE SYSTEM ERROR 2367. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88146 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR HOMECHOICE