BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3033844 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08331
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 RELEVANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A SYSTEM ERROR 2240 DURING THE DWELL STAGE, WHERE THE HOME PATIENT INDICATED BAGS WERE NOT CONNECTED PROPERLY, THE SUPPLY BAG HAD A LOOSE CONNECTION. THIS COMPLAINT IS CONFIRMED BECAUSE NOT PROPERLY CONNECTING THE BAGS IS A USE ERROR THAT CAN CAUSE THIS TYPE OF ALARM. PER THE PATIENT AT-HOME GUIDE, USERS ARE INSTRUCTED TO CHECK CONNECTIONS FOR SECURE FIT BEFORE BEGINNING THERAPY.

    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 2 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HOME PATIENT (HP) AIR HAD ENTERED THE SETUP. DURING TROUBLESHOOTING IT WAS FOUND THAT THE BAGS WERE NOT CONNECTED PROPERLY, THE SUPPLY BAG HAD A LOOSE CONNECTION. THE TSR HAD THE HP RECYCLE THE POWER AND SYSTEM ERROR 2367 ALARMED. THE TSR HAD THE HP CLOSE THE CLAMPS AND TRANSFER SET AND RECYCLE THE POWER TO PRESS GO TO START. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES AND INFORM THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) OF THE SYSTEM ERROR 2240. 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
    136818 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR HOMECHOICE