BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1984576 · Received February 11, 2011

    Report

    Report Number
    1423500-2011-01778
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 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). THIS COMPLAINT FOR A 2267 DURING FILL CYCLE 4/5 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE THE LOT NUMBER IS UNKNOWN, THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. A TREND REVIEW SHOWED NO ADVERSE TRENDS FOR COMPLAINTS RELATED TO SYSTEM ERROR 2267. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR ADVERSE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    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.

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2267 WHILE USING THE HOMECHOICE (HC) DURING THERAPY, IN FILL CYCLE 4 OF 5. THE PATIENT STATED THAT HE DISCONNECTED THE EMPTY HEATER BAG, RECONNECTED A NEW ONE, AND FORGOT TO PRESS "STOP". (B)(4) HAD THE PATIENT CYCLE POWER, AND THE HC WENT TO THE END OF THERAPY. (B)(4) EXPLAINED THAT THE ERROR INDICATED THAT AIR HAD ENTERED INTO THE DISPOSABLE SET. (B)(4) ADVISED THE PATIENT TO CONTACT THEIR NURSE. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO EXPLAINED THEY WERE ABLE TO CONTINUE THERAPY SUCCESSFULLY AND WAS DOING FINE SINCE THE ERROR OCCURRED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)