BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2120862 · Received June 11, 2011

    Report

    Report Number
    1423500-2011-07472
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    January 8, 2011
    Report Date
    January 27, 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED. AN INSTANCE OF IIPV WAS REVEALED IN THE LOGS. ROOT CAUSE: INSUFFICIENT DRAIN - FALSE EMPTY DETECT AT INITIAL DRAIN AND AT PREVIOUS THERAPY LAST DRAIN. REVIEW OF THE SERVICE DATES AND ACTIVITIES REVEALED THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR THE REPORTED PROBLEM OF IIPV. THE DEVICE MET SPECIFICATIONS. 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).

    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 CYCLE3. THE TOTAL DRAIN VOLUME WAS 3342ML. THIS DRAIN VOLUME MEETS BAXTER'S IIPV CRITERIA. THERE WAS PATIENT INVOLVEMENT, BUT 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 76 YR HOME CHOICE