BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1963041 · Received January 18, 2011

    Report

    Report Number
    1423500-2011-00730
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 25, 2010
    Report Date
    December 25, 2010
    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 IS FOR A REPORT OF A LEAK FOUND IN CASSETTE THOUGH ONE OF THE TUBES AND SPILLED SOLUTION OUT. THIS COMPLAINT WAS NOT CONFIRMED AND NO ROOT CAUSE WAS DETERMINED BECAUSE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. 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 SAMPLE IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    A CAREGIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A LEAK IN THE CASSETTE ON THE HOMECHOICE (HC) MACHINE DURING PRIME. THE CG STATED, THE CASSETTE STARTED LEAKING THROUGH ONE OF THE TUBES AND SPILLED SOLUTION OUT. THE CG STATED, THE HOME PATIENT HAD TURNED THE MACHINE OFF; HOWEVER, THE CG REQUESTED ASSISTANCE TO REMOVE THE DEFECTIVE CASSETTE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG TO REMOVE THE CASSETTE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. ON (B)(6) 2011 PRODUCT SURVEILLANCE SPOKE WITH THE HP'S DAUGHTER WHO STATED THAT THE HP VOLUNTARILY DECIDED TO DISCONTINUE TREATMENT. NO FURTHER DETAIL WAS PROVIDED; NO PRODUCT SAMPLE OR LOT INFORMATION IS AVAILABLE.

    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 78 YR HOMECHOICE APD SYSTEM