BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2200843 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10548
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 24, 2011
    Report Date
    July 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). THIS REPORT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS DUE TO USE ERROR, THERE WAS A CLAMP ON THE ORGANIZER THAT WAS OPEN. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN SET), WHICH OCCURRED ON THE HOMECHOICE DURING USE. THE PATIENT WAS CONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE PATIENT PERFORM MULTIPLE TROUBLESHOOTING STEPS. THE PATIENT STATED THERE WAS A CLAMP ON THE ORGANIZER THAT WAS OPEN. THE TSR EXPLAINED THE ALARM TO THE PATIENT AND EXPLAINED THE PROPER SET UP PROCEDURES. THE TSR ASSISTED THE PATIENT WITH CYCLING THE POWER OFF AND ON TO CLEAR THE SE 2240 AND RESULTANT SE 2367. THE PATIENT WOULD FINISH THEIR DRAIN WITH A MANUAL BAG. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN) ON (B)(6) 2011 REGARDING THE REPORTED SE 2240. THE RN STATED THEY WERE AWARE OF THE ALARM AND HAD REVIEWED PROPER PROCEDURES WITH THE PATIENT. RN STATED THE PATIENT WAS CONTINUING THERAPY ON THE CYCLER SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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 64 YR HOMECHOICE