BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3232499 · Received July 18, 2013

    Report

    Report Number
    1416980-2013-18787
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 22, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS NOT AVAILABLE; THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING FOLLOW UP WITH THE CAREGIVER (CG), IT WAS REPORTED THAT THERE WERE TWO BAGS ON THE HEATER PAN STACKED ON TOP OF EACH OTHER AT THE TIME OF THE EVENT. THE CG STATED THAT THE PRESSURE FROM THIS CAUSED THE LINE TO LEAK. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD INFORMED THEM TO ONLY HAVE ONE BAG ON THE HEATER PAN. SINCE THEY HAVE BEEN ONLY PUTTING ONE BAG ON THE HEATER PAN, THERE HAVE BEEN NO FURTHER LEAKS. THE CG STATED THAT THEY WERE ABLE TO CONTINUE THERAPY ON AFTER THE EVENT USING NEW SUPPLIES WITH NO DIFFICULTIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN "THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE", WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE INSTRUCTS THE USER TO PLACE ONE BAG ON THE HEATER PAN. THE GUIDE ALSO WARNS THE USER TO NOT STACK BAGS ON TOP OF EACH OTHER. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASSETTE WAS LEAKING DURING USE, WHILE THE HOME PATIENT (HP) WAS NOT CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO START THE THERAPY 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
    333349 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOMECHOICE