BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3070765 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-09984
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A SYSTEM ERROR 2240 DURING THE INITIAL DRAIN STAGE, WHERE THE HOME PATIENT INDICATED THE PATIENT LINE WAS NOT PRIMED PROPERLY WHEN PATIENT CONNECTED. THE CAUSE FOR THE INCOMPLETE PRIME WAS NOT DETERMINED. THIS COMPLAINT IS CONFIRMED BECAUSE AN INCOMPLETE PRIME IS A KNOWN CAUSE OF A SYSTEM ERROR 2240 ALARM. PER THE PATIENT AT-HOME GUIDE, USERS ARE INSTRUCTED TO CHECK THE LINES ARE COMPLETELY PRIMED BEFORE CONNECTING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN SET) AND SE2367, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED AIR ALARM. THE PATIENT LINE WAS NOT PRIMED PROPERLY WHEN PATIENT CONNECTED. THE TSR EXPLAINED PROPER PROCEDURES AND WHEN THEY NEED TO CONNECT. THE TSR SAID ALL NEW SUPPLIES NEED TO BE USED AND THE REGISTERED NURSE (RN) NEEDED TO BE NOTIFIED. THE TSR HAD THEM CYCLE THE POWER TO GET SYSTEM ERROR 2367 AND AGAIN TO GET BACK TO THE START. THE PATIENT WILL START OVER WITH NEW SUPPLIES. THE SAMPLES ARE UNAVAILABLE FOR EVALUATION. 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
    172257 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR HOMECHOICE