BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3030691 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08093
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING PERITONEAL DIALYSIS, DRAIN 4 OF 4. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. THE HP CHECKED THE CASSETTE'S PATIENT LINE AND FOUND AIR ALL THE WAY THROUGH THE LINE AND INTO THE TRANSFER SET TUBING. THE CAUSE OF THE AIR IN THE LINE WAS NOT DETERMINED DURING TROUBLESHOOTING BY THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR). THE HP CYCLED THE POWER OFF AND ON TO CLEAR THE SYSTEM ERROR 2240 WHICH WAS FOLLOWED BY A SYSTEM ERROR 2367. THERAPY WAS THEN ENDED. THE TSR HAD THE HP DISCONNECT USING ASEPTIC TECHNIQUE AND REMOVE THE CASSETTE. THE TSR ADVISED THE HP TO NOTIFY THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) AS SOON AS POSSIBLE. 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
    134079 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR HOMECHOICE