BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2994298 · Received March 8, 2013

    Report

    Report Number
    1416980-2013-05583
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) IS CONFIRMED BECAUSE THE CUSTOMER REPORTED THAT THE PATIENT LINE WAS NOT PROPERLY PRIMED BEFORE CONNECTING TO THE SET; INCOMPLETE PRIME IS A KNOWN CAUSE OF SE 2240 ALARM. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE. ON PAGE 3-2 THE USER INSTRUCTIONS STATE THAT, AFTER PRIMING, DO NOT CONNECT TO YOUR PATIENT LINE UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. CONNECTING WHEN AIR IS PRESENT WILL RESULT IN STERILE AIR BEING DELIVERED DURING THE FIRST FILL IF THERE WAS NO INITIAL DRAIN. AIR INTRODUCED INTO YOUR PERITONEAL CAVITY CAN CAUSE SHOULDER AND/OR ABDOMINAL PAIN AND MAY LEAD TO SERIOUS INJURY. ON PAGE 15-64, IF THE FLUID LEVEL IS NOT AT OR NEAR THE CONNECTOR AT THE END OF THE PATIENT LINE, FOLLOW THE STEPS BELOW TO REPRIME THE PATIENT LINE. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE RELATED USE ERROR(S) IN THE COMPLAINT. 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. PER THE CUSTOMER THE SAMPLE WAS NOT AVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240/2367 ALARM, THAT OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING INITIAL DRAIN. THE PATIENT WAS CONNECTED EITHER AT THE TIME OF THE ALARM OR OBSERVED AIR. THE PATIENT LINE WAS NOT PROPERLY PRIMED BEFORE CONNECTING. PATIENT EXTENSION LINES WERE NOT USED. THE SUPPLIES WERE NOT DAMAGED BY AN OUTLET PORT CLAMP OR AN ASSIST DEVICE USED TO MAKE THE CONNECTIONS. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE REPORTER. THE HOME PATIENT (HP) WOULD COMPLETE THERAPY WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98601 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