BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2061431 · Received April 18, 2011

    Report

    Report Number
    1423500-2011-04648
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 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 FOR AN OVERPRIME WAS NOT CONFIRMED IN THE LAB DUE TO UNAVAILABLE SAMPLE. A ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS NOT PERFORMED SINCE LOT NUMBER WAS NOT AVAILABLE. NO USER ERROR WAS SUSPECTED THEREFORE NO LABEL REVIEW WAS PERFORMED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    A CAREGIVER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH SETTING UP THE HOMECHOICE (HC) FOR THERAPY. THE CAREGIVER STATED SOLUTION KEPT SPILLING OUT OF THE PATIENT LINE DURING PRIMING. GTS VERIFIED THE LINES WERE IN THE ORGANIZER AND DETERMINED THAT THE PATIENT LINE AND DRAIN LINES WERE SWITCHED. THE CAREGIVER STATED SHE MIGHT HAVE BEEN THE ONE TO SWAP THE LINES. THE PATIENT LINE WAS CURRENTLY LAYING IN THE TUB. GTS ADVISED THE CAREGIVER TO START OVER WITH NEW SUPPLIES. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HOMECHOICE