BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3072884 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10076
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). (SAME DEVICE, PATIENT, AS (B)(4).)THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS CONFIRMED BY REVIEW OF THE LOGS. THE CAUSE OF THE IIPV WAS DETERMINED TO BE ONE OR MORE CYCLES ADVANCED TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. 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 2. THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME (LPFV) WAS 2000 ML AND THE DRAIN VOLUME WAS 3321 ML, WHICH MET IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174275 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE