BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2240631 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11928
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    September 2, 2011
    Report Date
    September 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A SYSTEM ERROR 2240 ALARM (AIR IN THE SET). A COMPANION SAMPLE WAS RETURNED AND EVALUATED. THE COMPLAINT IS NOT CONFIRMED AS THE ALARM WAS NOT DUPLICATED. THE CAUSE IS UNDETERMINED. A BATCH REVIEW REVEALED NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH THE HOMECHOICE (HC) UNIT DURING DWELL 1. PER THE INITIAL REPORT, HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN THE LINE). THE CALLER CYCLED THE POWER. THE TECHNICAL SERVICE REPRESENTATIVE ADVISED THE CALLER TO USE NEW DISPOSABLES. GLOBAL PRODUCT SURVEILLANCE CONTACTED HP ON (B)(6) 2011. THE HP WAS ABLE TO COMPLETE THERAPY WITH NEW SUPPLIES. THE HP DID NOT NOTICE ANY DEFECTS WITH THE ORIGINAL CASSETTE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H11F17057

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR HOMECHOICE