BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4092982 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31488
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    April 14, 2014
    Report Date
    August 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS COMPLETED. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED IN THE EVENT HISTORY LOG REVIEW. IT WAS DETERMINED THAT THE CAUSE OF THE IIPV EVENT WAS DUE TO A FALSE EMPTY DETECT AND USE ERROR, FURTHER SPECIFIED AS AN INAPPROPRIATE BYPASS OF A LOW DRAIN VOLUME (LDV) ALARM DURING THE INITIAL DRAIN. THE HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE PROVIDES INSTRUCTIONS ON HOW TO BYPASS A LDV ALARM. THE GUIDE WARNS THAT BYPASSING A LDV ALARM WHEN THERE IS STILL FLUID LEFT IN THE PERITONEAL CAVITY CAN RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED DURING THE THERAPY INITIATED ON (B)(6) 2014 AT 21:10:56. DURING NIGHT DRAIN CYCLE ONE, THE PATIENT'S ULTRAFILTRATION READING WAS 2194ML, INDICATING THE HOME PATIENT (HP) DRAINED 2194ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2000ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573740 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1