BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1982508 · Received February 9, 2011

    Report

    Report Number
    1423500-2011-01681
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LEAK WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A SAMPLE EVALUATION WAS NOT PERFORMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. A POSSIBLE CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. 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.

    Description of Event or Problem · 1

    A CAREGIVER CONTACTED (B)(4) REGARDING ASSISTANCE WITH NEEDING TO END THERAPY WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. THE CAREGIVER STATED THAT ONE OF THE TUBES WAS LEAKING, AND THEY WANTED TO END THERAPY. (B)(4) ASSISTED THE CAREGIVER IN ENDING THERAPY, AS REQUESTED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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