BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2241243 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11948
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 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). ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS IN (B)(4). THE SET WAS PLACED ON MACHINE FOR PRIMING AND RUN WITH NO ALARMS NOTED. NO MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. THE COMPLAINT COULD NOT BE CONFIRMED IN THE LAB AND THE CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    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'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) ALARM SITUATION 2240 (AIR IN LINE), THIS SITUATION OCCURRED DURING DWELL 2. THE PATIENT WAS ASKED IF ANY BAG CAME UNDONE AND THE PATIENT STATED NO SO THE ALARM WAS EXPLAINED. THE PATIENT WOULD FINISH WITH A MANUAL BAG. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER CONTACTED THE PATIENT ON (B)(6) 2011. THE PATIENT STATED THE FOLLOWING: THE CAUSE WAS OF THE ALARM WAS UNKNOWN AND MANUALS WERE USED TO COMPLETE THERAPY. THE SAMPLE WAS DISCARDED AND A COMPANION SAMPLE WAS AVAILABLE AND REQUESTED WITH LOT NUMBER H11E24089. NO PATIENT INJURY OR MEDICAL INTERVENTION 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 H11E24089

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR HOME CHOICE