BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2973975 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04444
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE AT THIS TIME. 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). A SERVICE HISTORY REVIEW (SHR) REVEALED THAT NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE IIPV-ADULT. A DEVICE HISTORY WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE IIPV IN THE LOGS DURING THE MANUFACTURE OF THE LOT OR SERIAL NUMBER. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED IN THE DEVICE LOG WAS USE ERROR, INAPPROPRIATE BYPASS OF THE DRAIN, NOT INCLUDING INITIAL-DRAIN.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT DRAINING DIFFICULTY ON THE HOMECHOICE (HC) MACHINE DURING USE, PATIENT CONNECTED IN DRAIN 1. THE CAREGIVER STATED THAT IN DRAIN 1 THE HOME PATIENT (HP) WASN'T DRAINING WELL, SO THE REGISTERED NURSE (RN) BYPASSED THE HP TO FILL 2. THEN DURING DWELL 2, THE HP STATED TO FELL OVERFILLED. PER CG THE HP'S FILL VOLUME WAS 2800ML FOR CYCLE 1. THE RN CHANGED THE FILL VOLUME TO 2500ML FOR CYCLE 2. THE HP WAS NOW IN CYCLE 3 AND THEY CHANGED THE FILL VOLUME AGAIN TO 2300. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE ULTRAFILTRATION (UF). IN CYCLE 1 THE UF WAS -877ML AND IN CYCLE 2 WAS 1863ML. THE HP DID NOT CURRENTLY HAVE SYMPTOMS. THE TSR EXPLAINED BYPASSED PROCEDURE AND POSSIBLE CAUSES OF FEELING OVERFILLED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED. THIS EVENT MEETS OVERFILL CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77670 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR