BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1951678 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00211
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO THE LACK OF A SAMPLE; THEREFORE, THE ASSIGNABLE CAUSE WAS NOT DETERMINED. THE LOT INFORMATION WAS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    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 NURSE CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. GTS EXPLAINED THAT THE SYSTEM ERROR INDICATED A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET AND ADVISED THE NURSE TO CYCLE POWER TWICE TO CLEAR THE ERROR. GTS THEN EXPLAINED THE NURSE WOULD NEED TO START OVER WITH NEW SUPPLIES. GTS ALSO ADVISED THE NURSE TO CONTACT THE PATIENT'S DIALYSIS NURSE IN THE NEXT 24 HOURS. PRODUCT SURVEILLANCE CONTACTED THE NURSE WHO EXPLAINED THE TWIST CLAMP ON THE TRANSFER SET WAS CLOSED, WHICH MAY HAVE CAUSED THE ERROR. THE NURSE STATED THERE WERE NO PROBLEMS WITH THE CASSETTE OR CYCLER AND THE PATIENT WAS ABLE TO CONTINUE THERAPY SUCCESSFULLY WITH NEW SUPPLIES. 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 HOMECHOICE APD CYCLER