BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2241259 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11951
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 29, 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. 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. THE SET WAS PLACED ON MACHINE FOR PRIMING AND RUN WITH NO ALARMS NOTED. THE SET WAS THEN TESTED UNDERWATER AT 8 PSI WITH NO LEAK NOTED. NO MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. THE COMPLAINT COULD NOT BE CONFIRMED IN THE LAB AND THE CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) SYSTEM ERROR 2240 (AIR IN LINE), THIS SYSTEM ERROR OCCURRED DURING DWELL 4 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) BY EXPLAINING THE ALARM. THE PATIENT WAS INVOLVED, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER WAS CONTACTED BY THE CAREGIVER ON (B)(6) 2011. THE CAREGIVER STATED THE FOLLOWING: THE CAUSE WAS UNKNOWN AND MANUALS WERE USED TO COMPLETE THERAPY. THE SAMPLE WAS DISCARDED AND A COMPANION SAMPLE WAS AVAILABLE AND REQUESTED WITH LOT NUMBER H11D05032. THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS THE NEXT DAY AND NO PATIENT INJURY WAS 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 H11D05032

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR HOME CHOICE