BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3190634 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16451
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 3, 2013
    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 RETURNED FOR EVALUATION. REVIEW OF THE DEVICE LOGS FOUND A DRAIN VOLUME THAT MEETS THE CURRENT CRITERIA OF AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) INCIDENT ((B)(6) 2013 AT 11:36 / CYCLE 3 / DRAIN 4803ML, LARGEST FILL VOLUME = 3000ML). THE CAUSE OF THE IIPV WAS DETERMINED TO BE DUE TO INSUFFICIENT DRAIN, ONE OR MORE CYCLES ADVANCED TO THE NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. THE DEVICE MET SPECIFICATIONS FOR THE IIPV FOUND DURING A MANUAL DOWNLOAD OF THE DEVICE LOGS. THE DEVICE WAS SENT FOR SERVICING. THIS IS AN ANCILLARY COMPLAINT FOUND DURING EVALATION OF (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE LOGS OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED DURING CYCLE 3. THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME (LPFV) WAS 3000ML AND THE DRAIN VOLUME WAS 4803ML. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290109 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE