BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2013207 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-02986
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 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). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. ROOT CAUSE IS DETERMINED TO BE USE ERROR - INCOMPLETE CONNECTION. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    A CAREGIVER CONTACTED (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. (B)(4) HAD THE PATIENT INSPECT THE PATIENT LINE. THE PATIENT STATED THE CONNECTION WAS LOOSE AND CAME APART. (B)(4) ADVISED THE PATIENT TO START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S CAREGIVER WHO EXPLAINED THE PATIENT WAS NOT CONNECTED AT THE TIME OF THE ERROR. THE CAREGIVER HEARD THE ERROR AND THEN REALIZED THE PATIENT WAS NOT CONNECTED TO THE HC. THE CAREGIVER STATED THE LOOSE CONNECTION WAS NOT A DEFECT OF THE DISPOSABLES, BUT WAS LOOSE DUE TO USE ERROR. THE PATIENT STARTED OVER WITH NEW SUPPLIES AND EVERYTHING WORKED OUT FINE. NO 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 H10K13041

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HOMECHOICE PRO