BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4821936 · Received June 5, 2015

    Report

    Report Number
    1416980-2015-24289
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    April 29, 2015
    Report Date
    May 13, 2015
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL AND ELECTRICAL TESTING OF THE DEVICE. INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED AND NO ISSUES WERE NOTED. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE EVENT. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THIS ISSUE WAS DETERMINED TO BE FALSE EMPTY DETECT AND USE ERROR, INAPPROPRIATE BYPASS OF THE CAUTION: NEGATIVE UF ALARM. THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE GIVES INSTRUCTIONS ON HOW TO BYPASS CAUTION: NEGATIVE UF ALARM. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 (IIPV) EVENT WAS IDENTIFIED. THIS EVENT OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2015 AT 01:49:05. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 1853ML, INDICATING THE HOME PATIENT DRAINED 1853ML 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
    365525 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR