BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3921174 · Received July 9, 2014

    Report

    Report Number
    1416980-2014-21895
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS PENDING. UPON COMPLETION OF THE INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED SYSTEM ERROR 2240 ALARM. A VISUAL INSPECTION, LEAK TESTING, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. CLEAR PASSAGE TESTING AND SIMULATED USE TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE SAMPLE EVALUATION DID NOT VERIFY THE REPORTED PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR 2240 ALARM (AIR IN SET/LINE) OCCURRED ON THE HOMECHOICE DEVICE DURING DRAIN 5 OF 5 OF PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. DURING TROUBLESHOOTING, THERE WAS NOTHING UNUSUAL FOUND WITH THE SUPPLIES OR THE SETUP THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE PATIENT IN ENDING THERAPY. 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
    400036 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HOMECHOICE