BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOME CHOICE PRO

    MDR report key: 4220012 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38367
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    December 10, 2009
    Report Date
    October 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Removal / Correction Number
    1423500-01/08/10-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED FOR THE REPORTED EVENT. A REVIEW OF THE EVENT HISTORY LOG VERIFIED THE OCCURRENCE OF AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE FALSE EMPTY DETECT AND USE ERROR WITH INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED. HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE GIVES THE WARNING THAT "TOO LOW AN I-DRAIN ALARM VOLUME CAN RESULT IN AN INCOMPLETE INITIAL DRAIN FOLLOWED BY A FULL FILL. THIS CAN RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD RELEVANT ADDITIONAL 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. THE EVENT OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2009, AT 10:10:06. DURING NIGHT DRAIN CYCLE ONE, THE PATIENT'S ULTRAFILTRATION READING WAS 297ML, INDICATING THE HOME PATIENT (HP) DRAINED 297ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 200ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704004 HOME CHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1