BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 3260130 · Received August 1, 2013

    Report

    Report Number
    1416980-2013-20385
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR SYSTEM ERROR 2240, WHERE THE HOME PATIENT (HP) CONNECTED PATIENT LINE EXTENSION SET AFTER THE PRIMING CYCLE OF THE THERAPY WAS COMPLETED. 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. IT INSTRUCTS THE USER TO CONNECT THE PATIENT LINE EXTENSION TO THE PATIENT LINE PRIOR TO PRIMING. ALSO, IT INSTRUCTS THE USER TO MAKE SURE THE PATIENT LINE EXTENSION IS CORRECTLY POSITIONED IN THE ORGANIZER AND VERIFY THAT THE PATIENT LINE EXTENSION IS PLACED IN THE LEFT SLOT OF THE BLUE ORGANIZER. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ANY RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN TUBING) ON THE HOMECHOICE (HC) DURING THE INITIAL DRAIN, WHILE THE HP WAS CONNECTED. THE HP WAS USING EXTENSION LINE BUT DID NOT CONNECT IT TO THE PATIENT LINE PRIOR TO PRIMING. AS A RESULT, THE PATIENT LINE EXTENSION SET DID NOT GET PRIMED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ITS CAUSE. THE TSR HAD THE HP CLOSE ALL THE CLAMPS AND CYCLE THE POWER IN ORDER TO CLEAR THE ALARM. THE TSR ADVISED THE HP TO START THE THERAPY OVER. 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
    360547 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOMECHOICE| HOMECHOICE AUTOMATED PD SET WITH CASSETTE