BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2133960 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07852
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 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). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR AN OVERPRIME - LEAK OUT OF PATIENT LINE. FROM THE EVENT DESCRIPTION, IT STATES THAT THE PATIENT REPORTED TO HAVING TWO BAGS ON THE HEATER PAN. THIS IN TURN WOULD CAUSE AN OVERPRIME AND A LEAK OUT OF THE PATIENT LINE DUE TO THE GRAVITY OF THE BAGS TO THE PATIENT LINE. THE REPORT WAS CONFIRMED AS USE ERROR AND THE ASSIGNABLE CAUSE WAS DETERMINED AS WELL. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(4) REGARDING ASSISTANCE WITH REPRIMING THE PATIENT LINE ON THE HOMECHOICE MACHINE(HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO PRESS STOP AND THEN THE DOWN ARROW TO REPRIME THE PATIENT LINE. THE TSR ASSISTED THE HP TO PRESS ENTER. THE TSR ASSISTED THE HP TO CHECK THAT THE PATIENT LINE WAS IN THE ORGANIZER. THE HP STATED IT WAS IN THE ORGANIZER AND THE CLAMP IS OPEN. THE TSR ASSISTED THE HP TO PRESS ENTER TO START THE REPRIME. THE HP STATED THAT THE LINE IS FULL AND COMING OUT OF THE TOP. THE TSR CONFIRMED WITH THE HP THAT THERE WERE TWO BAGS ON TOP OF THE HC. THE TSR EXPLAINED TO THE HP THAT THE PATIENT LINE PRIMES BY GRAVITY AND IT WILL REACH A LEVEL EQUAL TO THAT OF THE BAGS THAT ARE ON TOP OF THE HC. THE HC MOVED TO "CONNECT YOURSELF". THE TSR ADVISED THE HP TO MOVE THE BAG WITH THE WHITE CLAMP LINE TO THE SIDE OF THE HC IN THE FUTURE. THE HP STATED THEY UNDERSTOOD AND WOULD START THERAPY WHEN THEY WERE READY. THERE WAS PATIENT INVOLVEMENT. NO INJURY OR MEDICAL INTERVENTION WAS 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 73 YR HOMECHOICE CYCLER