BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3211110 · Received July 8, 2013

    Report

    Report Number
    1416980-2013-17720
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE SYSTEM ERROR 2240 WAS DETERMINED TO BE DUE TO USE ERROR - PATIENT NOT CONNECTED WHEN THE THERAPY WAS INITIATED. 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 PROVIDES STEP-BY-STEP INSTRUCTIONS FOR WHEN AND HOW TO CONNECT TO THE DISPOSABLE SET. THE GUIDE INSTRUCTS THE USER TO CONNECT THE TRANSFER SET TO THE PATIENT LINE PRIOR TO STARTING THE INITIAL DRAIN. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INITIAL DRAIN OF PERITONEAL DIALYSIS (PD) THERAPY, A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) OCCURRED ON THE HOMECHOICE (HC) DEVICE. THE PATIENT WAS NOT CONNECTED WHEN THE ALARM OCCURRED, HOWEVER, THE REGISTERED NURSE (RN) CONNECTED THE HP AFTER THE ALARM OCCURRED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE RN THAT THE SE 2240 INDICATES AIR IN THE SETUP AND THAT THE PATIENT SHOULD NOT BE CONNECTED ONCE THE ALARM OCCURS AND ALSO ADVISED THAT THE PATIENT NEEDED TO BE CONNECTED PRIOR TO PRESSING GO. THE RN RECYCLED THE POWER AND SE 2367 ALARMED (FAIL SAFE SHUT DOWN). THE TSR ADVISED THE RN THAT THE THERAPY WOULD NEED TO BE STARTED OVER WITH NEW SUPPLIES. THE TSR ASSISTED THE RN TO RECYCLE THE POWER TO "PRESS GO TO START." THE RN WOULD START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311250 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HOMECHOICE