BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2000673 · Received February 24, 2011

    Report

    Report Number
    1423500-2011-02417
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED OPERATIONAL BUT WITH A CRACKED COVER. THE DEVICE WAS FUNCTIONING WITHIN SPECIFICATION. A REVIEW OF THE DEVICE LOGS REVEALED A DRAIN VOLUME THAT MEETS THE IIPV (INCREASED INTRA-PERITONEAL VOLUME) CRITERIA. THE PAL EVALUATED THE DEVICE. WITH REFERENCE TO THE IIPV DECISION TREE, THE CAUSE FOR THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN. ONE OR MORE CYCLES ADVANCE TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE IIPV. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THE IIPV OCCURRED ON (B)(6) 2011 DURING DRAIN CYCLE 4. THE PROGRAMMED FILL VOLUME WAS 1400ML AND THE TOTAL DRAIN VOLUME WAS 2497ML. THIS DRAIN VOLUME MEETS BAXTER'S IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR