BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1880441 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04816
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 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 HOME PATIENT (HP) HAD INDICATED THAT THE HOMECHOICE (HC) WAS JUMPING TO FILL 1 WITHOUT DRAINING. THE ISSUE WAS NOT CONFIRMED. THE CAUSE FOR THE REPORTED ISSUES WAS DETERMINED TO BE USE ERROR. A SERVICE HISTORY REVIEW (SHR) REVEALED NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED USE ERROR. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE SUFFICIENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). RESOLVED OVER THE PHONE. 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING JUMPS TO FILL1 WITHOUT DRAINING, WHICH OCCURRED ON THE HOME CHOICE (HC). THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE INITIAL DRAIN SETTING. IT IS AT 0ML. THE HOME PATIENT (HP) DOES A 2L MANUAL BAG AND HAS TO DO A MANUAL DRAIN EVERYDAY AFTER THE INITIAL DRAIN DOES NOT PULL ANYTHING. THE TSR EXPLAINED THE PROBLEM. THE HP ALSO HAS THE HC ABOUT 30 INCHES ABOVE HER. THE TSR EXPLAINED THE PROPER HEIGHT FOR THE HC AND WHAT ALARMS AND PROBLEMS THAT CAN CAUSE ACCORDING TO THE PATIENT AT HOME GUIDE. THE STATES HER NURSE NEVER TOLD HER THIS. THE TSR EXPLAINED SHE SHOULD STILL LISTEN TO HER. THE HP WILL SPEAK TO THE REGISTERED NURSE ON THE NEXT VISIT THIS WEEK. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HP'S DIALYSIS NURSE, (B)(6), ON (B)(6) 2010. THE NURSE STATED THAT THE INITIAL DRAIN ALARM HAD BEEN ADJUSTED AND THE HP WAS ABLE TO CONTINUE THERAPY WITHOUT COMPLICATION. 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 47 YR