BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2994366 · Received March 8, 2013

    Report

    Report Number
    1416980-2013-05588
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A SYSTEM ERROR 2240 DURING THE DWELL STAGE. THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER AND THERE WAS NO REPORT OF USE ERROR OR ISSUES THAT MIGHT HAVE CAUSED THE ALARM. THE LOT NUMBER WAS NOT PROVIDED, SO NO BATCH REVIEW COULD BE PERFORMED. AS SUCH, THE ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN SET) DURING DWELL ON THE HOMECHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO CLEAR THE ERROR AND INFORMED THE HP OF THE ERRORS MEANING. THE HP WOULD CONTINUE THERAPY WITH A MANUAL EXCHANGE BY DRAINING FOR THE DAY AND WOULD ALSO CONTACT THE NURSE REGARDING THE SYSTEM ERROR. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98737 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOMECHOICE