BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4153375 · Received October 8, 2014

    Report

    Report Number
    1416980-2014-35069
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVENT INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. MISUSE OF PERITONEAL DIALYSIS DEVICE(S) IS A KNOWN CAUSE OF THIS EVENT. 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 WARNS THE USER TO FOLLOW ASEPTIC TECHNIQUE TAUGHT BY THE DIALYSIS CENTER WHEN HANDLING LINES AND SOLUTION BAGS TO REDUCE THE POSSIBILITY OF INFECTION. ALSO, IT WARNS THE USER THAT MISUSE CAN RESULT IN CONTAMINATION OF THE FLUID OR FLUID PATHWAYS. 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 A HOME PATIENT (HP) FAILED TO FOLLOW THERAPY STEPS ON THE HOMECHOICE DEVICE, DURING INITIAL DRAIN. THE HP WAS CONNECTED AT THE TIME OF THE EVENT. THE FAILURE TO FOLLOW THERAPY STEPS WAS FURTHER DESCRIBED AS THE PATIENT USING TOO MANY PATIENT EXTENSION LINES. DURING TROUBLESHOOTING, IT WAS NOTED THAT THE HP HAD FOUR EXTENSION LINES CONNECTED INSTEAD OF THE RECOMMENDED MAXIMUM OF TWO EXTENSION LINES. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE HP TO END THERAPY AND ADVISED THE HP TO CONTACT THEIR NURSE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630541 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HOMECHOICE