BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3000480 · Received March 12, 2013

    Report

    Report Number
    1416980-2013-05943
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) AND IT WAS REPORTED THAT PATIENT DISCONNECTED HIMSELF FROM DISPOSABLE SET; LINE DISCONNECTION (WITH OUT PROPER EMERGENCY DISCONNECT PROCEDURE) DURING THERAPY IS A KNOWN CAUSE OF SE 2240 ALARM. NOTE: USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE (US 07-19-63-293) ISSUED ON JULY 2010 AND RELATED DIRECTION SHEET. BAXTER TRAINING MANUAL AND LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USE ERRORS.

    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. 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. 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 BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN SET) ON THE HOMECHOICE (HC) DURING PERITONEAL DIALYSIS, IN DWELL. THE HOME PATIENT (HP) HAD DISCONNECTED PRIOR TO THE SE AND HAD NOT FOLLOWED PROPER DISCONNECT PROCEDURES. THE HP THEN RECONNECTED AND RECEIVED THE SE. THE HP CYCLED THE POWER OFF/ON TWICE AND THE SE DID NOT REPEAT. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103186 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR HOMECHOICE