BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2072018 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05144
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 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 COMPLAINT OF OVERPRIME WAS CONFIRMED AND THE CAUSE WAS IDENTIFIED BASED ON THE USER'S REPORT THAT THERE WERE THREE BAGS STACKED ON THE HEATER PAN, USE ERROR. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE PATIENT LINE LEAKING OUT THE END. THE LINE WAS IN THE ORGANIZER. THE CARE GIVER (CG) WAS TOLD BY THE NURSE THAT SUPPLIES ARE COMPROMISED AND THE HOME PATIENT (HP) SHOULD START OVER. THE CG STARTED OVER AGAIN, AND WHEN THE SAME THING HAPPENED, THE CG CALLED THE NURSE AGAIN, WHO TOLD THE CG THAT THE HOMECHOICE (HC) IS DEFECTIVE AND THE HP NEEDS ANOTHER ONE. AFTER TROUBLESHOOTING WITH THE CG, THE TECHNICAL SERVICE REPRESENTATIVE (TSR) DISCOVERED THAT THE CG HAD THREE BAGS STACKED ON THE HEATER. THE TSR EXPLAINED THAT SINCE THERE ARE THREE BAGS ON THE HEATER TRAY, THE SOLUTION WOULD DEFINITELY COME OUT OF THE END OF THE PATIENT LINE BECAUSE NOW, THE TOP OF THE SOLUTION BAG IS MUCH HIGHER THAN IF THERE WAS ONLY ONE. THE TSR EXPLAINED THAT THE CG SHOULD NOT STACK BAGS ON THE HEATER, BUT LAY EXTRA BAGS ON A FLAT SURFACE, THEN EXPLAINED THAT THE PATIENT LINE CAP IS VENTED TO ALLOW THE AIR TO ESCAPE WHILE PRIMING AND THAT SUPPLIES WERE NOT COMPROMISED AND THE HC IS WORKING PROPERLY. THE CG UNDERSTOOD AND THE HP IS READY FOR THERAPY TO BEGIN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    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 76 YR HOMECHOICE CYCLER