BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1901986 · Received November 18, 2010

    Report

    Report Number
    1423500-2010-05911
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 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). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    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 CANNOT BE DETERMINED. THE LOT INFORMATION WAS UNAVAILABLE; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CAREGIVER AND PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING DRAIN 2 OF 9. GTS HAD THE PATIENT CLOSE ALL THE CLAMPS AND TRANSFER SET, AND CYCLE POWER TWICE TO THE "PRESS GO TO START" PROMPT TO CLEAR THE ERROR. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET. THE CAREGIVER STATED THAT SHE SETUP THE HC AGAIN A SECOND TIME AND IT ALARMED WITH THE SYSTEM ERROR 2240. THE CAREGIVER STATED THEY USE ALL FOUR SUPPLY LINES, THE PATIENT DID NOT DISCONNECT, THERE WERE NO PATIENT LINE EXTENSIONS IN USE, THE HC PRIMED OK, AND THERE WAS NO AIR IN THE SYSTEM AT THE START OF THE THERAPY. GTS EXPLAINED THEY SHOULD DISCARD ALL THE SUPPLIES AND REPORT THE ALARMS TO THE PATIENT'S DIALYSIS NURSE THE NEXT MORNING. THE PATIENT ELECTED TO COMPLETE THERAPY MANUALLY. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S NURSE REGARDING THE SYSTEM ERROR. THE NURSE STATED THAT THE PATIENT DID NOTIFY HER OF THE ALARM AND THE PATIENT IS DOING JUST FINE. THE PATIENT DID NOT HAVE ANY ADVERSE EVENTS DUE TO THIS AND HAS BEEN ABLE TO CONTINUE THERAPY.

    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 43 YR