BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3243031 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19461
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR USE ERROR - BREACH IN ASEPTIC TECHNIQUE, WHERE A BREAK IN ASEPTIC TECHNIQUE OCCURRED WHEN THE HOME PATIENT RECONNECTED TO THE HC THAT HAS BEEN IN THERAPY ALREADY. THE INSTRUCTIONS LISTED IN THE PATIENT AT HOME GUIDE FOR THE HOMECHOICE DEVICE STATE TO FOLLOW ASEPTIC TECHNIQUE TAUGHT BY YOUR DIALYSIS CENTER WHEN HANDLING LINES AND SOLUTION BAGS TO REDUCE THE POSSIBILITY OF INFECTION. IT INSTRUCTS THE USER TO USE ASEPTIC TECHNIQUE TO REDUCE CHANCE OF INFECTION, THIS INCLUDES WHENEVER THE PATIENT IS CONNECTING THEMSELVES TO THE CYCLER, DISCONNECTING, OR ANY TIME THEY HANDLE FLUID LINES AND SOLUTION BAGS. IT INSTRUCTS PATIENTS TO PUT ON A FACE MASK AND WASH AND DRY/DISINFECT THEIR HANDS THOROUGHLY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ANY RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD RECONNECTED TO THE HOMECHOICE (HC) AFTER BEING DISCONNECTED FOR A PERIOD OF TIME. THE HC MACHINE WAS RUNNING AND MAKING A MESS WHILE IN DWELL 1 OF 5 WHEN THE HP RECONNECTED TO THE MACHINE. THE CARE GIVER (CG) MADE THE HP DISCONNECT FROM THE HC. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) STATED TO THE CG THAT THE HP SHOULD NEVER CONNECT WHILE THE MACHINE IS IN THE THERAPY DUE TO HAVING POSSIBLE AIR IN THE LINE. THE TSR ADVISED THE CG TO END THE THERAPY AND START OVER USING ALL NEW SUPPLIES. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342563 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR HOMECHOICE