BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2991085 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05364
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) IS NOT CONFIRMED BECAUSE DISPOSABLE SET WAS NOT RETURNED TO BAXTER FOR EVALUATION, THE LOT NUMBER WAS NOT PROVIDED FOR A BATCH REVIEW AND THE USER DID NOT DESCRIBE ANY TYPE OF USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED THE REPORTED EVENT. THE ASSIGNABLE CAUSE IS UNDETERMINED. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REPORTING A SYSTEM ERROR 2240/2367 (AIR IN SET) DURING DWELL 3 OF 5 ON THE HOMECHOICE (HC). THE HOME PATIENT (HP) WAS CONNECTED AND THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO CYCLE THE POWER TO CLEAR THE ALARMS AND EXPLAINED THE MEANING OF THE ALARMS. THERE WAS NO OBVIOUS CAUSE OF THE ALARM. THE CALLER WILL DISCARD THE SUPPLIES AND FINISH THERAPY WITH MANUAL SUPPLIES. THE CALLER WILL CALL THE REGISTERED NURSE (RN) REGARDING THE AIR DETECT ALARM AND BEING CONNECTED. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95143 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE