BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1971631 · Received January 27, 2011

    Report

    Report Number
    1423500-2011-01099
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    November 18, 2010
    Report Date
    January 13, 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 AND EVALUATED. AN IIPV: (OCCURRENCE DATE (B)(6) 2010 / CYCLE 4 / DRAIN VOLUME 4342 ML) WAS CONFIRMED IN THE LOGS, BUT NOT DUPLICATED DURING PAL EVALUATION. THE ROOT CAUSE: INSUFFICIENT DRAIN - FALSE EMPTY DETECT AND USE ERROR, INAPPROPRIATE BYPASS OF THE LOW DRAIN VOLUME ALARM. THE DEVICE WAS IN SPECIFICATION. A REVIEW OF THE PREVIOUS SERVICE RECORD WAS DONE. NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUE OF THE IIPV. LABELING WAS REVIEWED FOR RELATED USE ERROR(S) AND THERE WERE NO ISSUES AND NO LABEL DEFICIENCY. 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). EVALUATION OF THE DEVICE HAS BEGUN; HOWEVER, HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE EVALUATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    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) 2010 DURING DRAIN CYCLE 4. THE PROGRAMMED FILL VOLUME WAS 2399ML AND THE TOTAL DRAIN VOLUME WAS 4342ML. 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 CYCLER-REFURBISHED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOME CHOICE CASSETTE