BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3053503 · Received April 11, 2013

    Report

    Report Number
    1416980-2013-09054
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A SYSTEM ERROR 2240 DURING THE DWELL STAGE, WHERE THE HOME PATIENT STATED THAT THEY HAD OPEN CLAMP ON HIS UNUSED THE SUPPLY LINE. THIS COMPLAINT IS CONFIRMED BECAUSE LEAVING A CLAMP OPEN ON AN UNUSED SUPPLY LINE IS A USE ERROR THAT MAY CAUSE A SYSTEM ERROR 2240 AND CONTAMINATION. PER THE PATIENT AT-HOME GUIDE, USERS ARE INSTRUCTED TO LEAVE ANY UNUSED LINES IN THE ORGANIZER WITH CLAMPS CLOSED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN SET), WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 1 OF 4. THE HOME PATIENT (HP) STATED THAT THEY HAD OPEN CLAMP ON HIS UNUSED THE SUPPLY LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ERROR AND REVIEW PROPER SETUP PROCEDURE. THE TSR INFORMED THE HP THAT THEY WOULD HAVE TO SETUP THE HC WITH ALL NEW SUPPLIES. THE HP UNDERSTOOD AND WOULD SETUP WITH ALL NEW SUPPLIES. NO SAMPLES WERE PROVIDED FOR EVALUATION. THE HC WAS OPERATIONAL. 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
    154722 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR HOMECHOICE