BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2990426 · Received March 5, 2013

    Report

    Report Number
    1416980-2013-05320
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 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). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) IS NOT CONFIRMED BECAUSE DISPOSABLE SET WAS NOT RETURNED TO BAXTER FOR EVALUATION, LOT NUMBER WAS NOT PROVIDED FOR A BATCH REVIEW AND USER DID NOT DESCRIBE ANY TYPES 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

    IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240 (AIR IN CASSETTE) OCCURRED WITH A HOME CHOICE (HC) MACHINE DURING THE INITIAL DRAIN. TROUBLESHOOTING DID NOT REVEAL A CAUSE FOR THE ALARM. THE TSR ASSISTED THE HOME PATIENT (HP) TO CLEAR THE ALARMS SO THEY COULD SET UP AGAIN AND ADVISED THE HP TO CALL THE NURSE FOR FURTHER MEDICAL INSTRUCTIONS. THE TSR THEN LOST CONNECTION AND TRIED CALLING THE HP BACK SEVERAL TIMES; THE HP HAD CALLED BACK IN AND CONTACTED ANOTHER TSR TO COMPLETE ASSISTANCE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92913 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR HOMECHOICE