BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2183632 · Received July 29, 2011

    Report

    Report Number
    1423500-2011-09975
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 9, 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 AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE SUPPLY BAG BECAME DISCONNECTED FROM THE SUPPLY LINE. 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). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN SET) AND SE 2367, WHICH OCCURRED ON THE HOMECHOICE DURING USE DURING DWELL 3. THE PATIENT STATED THAT THE SUPPLY BAG WAS NOT FIRMLY ATTACHED TO THE LINE AND IT CAME UNDONE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARMS AND HAD THE PATIENT CYCLE THE POWER TWICE TO CLEAR THEM. THE TSR EXPLAINED THAT THE PATIENT WOULD NEED TO START OVER WITH NEW SUPPLIES AND REVIEWED THE PROPER PROCEDURES PER THE USER MANUAL. THE PATIENT STATED THEY WOULD USE MANUAL SUPPLIES. THE TSR ADVISED THE PATIENT TO CALL THEIR NURSE IN THE NEXT TWENTY FOUR HOURS AND LET THE NURSE KNOW ABOUT WHAT HAPPENED. THE PATIENT UNDERSTOOD THE EXPLANATIONS AND WOULD FOLLOW UP WITH THE NURSE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2011 REGARDING THE REPORTED SE 2240. THE PATIENT STATED THEY DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE SUPPLIES IN USE, AND WAS NOT SURE HOW THE BAG AND LINE BECAME DISCONNECTED. THE PATIENT INFORMED THEIR NURSE ABOUT THE ALARM AND THERAPY HAD BEEN GOING FINE SINCE. 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 54 YR HOMECHOICE