BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 5101387 · Received September 24, 2015

    Report

    Report Number
    1416980-2015-37114
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    May 21, 2015
    Report Date
    October 6, 2015
    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 RECEIVED AND THE EVALUATION IS COMPLETE. DURING THE EVENT HISTORY LOG REVIEW, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THIS ISSUE WAS DETERMINED TO BE USE ERROR, INAPPROPRIATE BYPASS OF THE DRAIN, NOT INCLUDING THE INITIAL DRAIN. THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE GIVES INSTRUCTIONS ON HOW TO BYPASS THE DRAIN PHASE. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2015 AT 23:12:36. DURING NIGHT DRAIN CYCLE SEVEN, THE PATIENT'S ULTRAFILTRATION READING WAS 1064ML, INDICATING THE HOME PATIENT DRAINED 1064ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1500ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630420 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1