BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2031885 · Received March 28, 2011

    Report

    Report Number
    1423500-2011-03740
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 27, 2011
    Report Date
    February 27, 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). PER THE CUSTOMER THE SAMPLE WAS DISCARDED, THEREFORE NO EVALUATION COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CHECK LINES AND BAGS ALARM AND AIR IN THE CASSETTE WERE NOT CONFIRMED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A CAUSE OF THE AIR WAS UNKNOWN; THEREFORE, AIR IN CASSETTE WAS NOT CONFIRMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION FOR CHECK LINES AND BAGS ALARMS IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    DURING A FOLLOW-UP CALL TO THE HOME PATIENT (HP) REGARDING A CHECK LINES AND BAGS ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING PRIME, THE HP REVEALED THAT SHE HAD NOTICED SOME AIR IN THE CASSETTE WHEN SHE WAS TAKING DOWN THE SUPPLIES. THE HP STARTED OVER WITH NEW SUPPLIES AND RESUMED THERAPY WITHOUT ANY PROBLEMS. 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 H10K05062

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR HC CYCLER