BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1940084 · Received December 29, 2010

    Report

    Report Number
    1423500-2010-07345
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    August 16, 2010
    Report Date
    December 4, 2010
    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). EVALUATION OF THE DEVICE HAS BEGUN; HOWEVER, HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE EVALUATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DISCONTINUED USE OF THE DEVICE AND RETURNED IT TO THE (B)(4). A LOG REVIEW REVEALED AN INCREASED INTRAPERITONEAL VOLUME (IIPV) HAD OCCURRED ON (B)(6) 2010 DURING CYCLE 11 WHEN THE USER DRAINED OUT 263 ML, WHICH WAS GREATER THAN 130% OF THE LARGEST PRESCRIBED FILL VOLUME OF 200 ML AND MET PEDIATRIC IIPV CRITERIA. THE DEVICE WAS FOUND TO MEET SPECIFICATIONS RELATIVE TO THE IIPV FOUND IN THE LOGS. THE ASSIGNABLE CAUSE OF THE PEDIATRIC IIPV FOUND IN THE LOGS WAS DETERMINED TO BE: INSUFFICIENT DRAIN. FALSE EMPTY DETECT AND USE ERROR. INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED AND ONE OR MORE CYCLES ADVANCE TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. REVIEW OF THE SERVICE DATES AND ACTIVITIES REVEALED THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR THE REPORTED PROBLEM OF THE PEDIATRIC IIPV. 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) 2010 DURING DRAIN CYCLE 11. THE PROGRAMMED FILL VOLUME WAS 200ML AND THE TOTAL DRAIN VOLUME WAS 263ML. 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 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO