BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1992147 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01998
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 21, 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 WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF A DISPOSABLE CASSETTE SAMPLE. THE CAUSE WAS UNDETERMINED. THE LOT NUMBER IS UNKNOWN, THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    EMAIL RECEIVED IN CORPORATE MAILBOX. PATIENT REPORTED THAT AFTER DRAIN ON THE HOME CHOICE (HC) CYCLER SHE NOTED WHEN SHE WAS FILLING THERE WAS A LOT AIR IN THE LINE GOING TO HER. PATIENT REPORTED HAVING SO MUCH AIR IN HER BELLY THAT SHE WAS UNCOMFORTABLE THROUGH THE NIGHT. UPON DRAINING SHE NOTED A HUGE AIR BUBBLE IN DRAIN BAG WHEN SHE WAS DRAINING SO MUCH SO THAT FLUID LEAKED OUT ONTO THE FLOOR FROM THE DRAIN BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE CYCLER