BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3030373 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08070
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE SYSTEM ERROR 2240 WAS AN INCOMPLETE PRIME, A KNOWN CAUSE OF THIS ALARM. THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED THEY CONNECTED, WENT TO BED, WOKE UP ,AND REALIZED THE HC HAD NOT GONE THROUGH PRIMING YET. THE HP STATED THEY THEN CLOSED THE TRANSFER SET AND PRESSED GO, AND THE HC PRIMED. THE HP THEN OPENED THE TRANSFER SET AND CONTINUED WITH THERAPY. THE PATIENT LINE DID NOT PRIME COMPLETELY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP THAT AIR HAD ENTERED THE SETUP AND THE HP WOULD NEED TO START OVER WITH NEW SUPPLIES. THE TSR HAD THE HP CYCLE THE POWER AND A SYSTEM ERROR 2367 ALARMED. THE TSR HAD THE HP CLOSE THE CLAMPS AND CYCLE THE POWER AGAIN TO GET TO 'PRESS GO TO START.' THE TSR EXPLAINED PROPER SETUP AND CONNECTION PROCEDURES TO PATIENT. THE HP WOULD START OVER WITH NEW SUPPLIES. 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
    135273 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE