BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2884016 · Received December 21, 2012

    Report

    Report Number
    1416980-2012-07965
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE WAS CONFIRMED IN THE EVENT HISTORY LOG REVIEW. THE CAUSE WAS DETERMINED TO BE UNEXPECTED HIGH UF FOR THERAPY COMPARED TO OTHER THERAPIES.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER?S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REGISTERED NURSE (RN) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A HIGH DRAIN 103 ALARM ON A HOMECHOICE PRO (HCP) DEVICE DURING DRAIN CYCLES 3 AND 4, WHILE THE PATIENT WAS CONNECTED. THE RN WAS UNSURE OF THE ULTRAFILTRATION (UF) AMOUNT WHEN THE HOME PATIENT (HP) TOLD HER 25 LITERS. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) CALLED THE HP TO RETRIEVE THE INFORMATION FROM THE HCP LOG. THE TOTAL UF WAS 25134ML, THE CYCLE 1 UF WAS EQUAL TO -445ML, THE CYCLE 2 UF WAS EQUAL TO -106ML, THE CYCLE 3 UF WAS EQUAL TO 18720ML (SEE MEDWATCH REPORT # 1416980-2012-07481), AND THE CYCLE 4 UF WAS EQUAL TO 6965ML (COVERED BY THIS MEDWATCH REPORT). THE FILL VOLUME WAS EQUAL TO 2300ML, AND THE LAST FILL VOLUME WAS EQUAL TO 2000ML. THE TOTAL FILL INCLUDING THE LAST FILL WAS 11227ML AND THE TOTAL DRAIN SHOWED 34362ML. THE INITIAL DRAIN ALARM WAS SET TO 15ML AND HP STARTS THERAPY EMPTY. THE HP STATED THAT HE NEVER DISCONNECTED AND REPORTED NO SYMPTOMS. THE HP STATED HE WAS FINE. THE TSR EXPLAINED NOT TO USE THE HCP AND EXPLAINED THE SWAP PROCEDURE. THE HP UNDERSTOOD. THE TSR PAGED THE RN BACK AND EXPLAINED EVERYTHING TO HER. SHE AGREED THAT SOMETHING WAS WRONG AND THE HCP NEEDED TO BE SWAPPED. THE TSR INITIATED A SWAP OF THE DEVICE. THE TSR DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW MACHINE ARRIVES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE