BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1844346 · Received September 24, 2010

    Report

    Report Number
    1423500-2010-03714
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 20, 2010
    Report Date
    September 1, 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 SUMMARY: THE DEVICE PASSED BOTH HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION(RITE) FUNCTIONAL AND ELECTRICAL TESTS, MEETING DEVICE PERFORMANCE SPECIFICATIONS. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED IN THE DEVICE LOG WAS NOT DUPLICATED DURING THE PRODUCT ANALYSIS LAB EVALUATION. THE CAUSE WAS INSUFFICIENT DRAIN- FALSE EMPTY DETECT AT INITIAL DRAIN. REVIEW OF THE SERVICE DATES AND ACTIVITIES REVEALED THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR THE ISSUE OF IIPV. ALSO 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, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    TWO INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATIONS WERE IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE (HC) DEVICE. THIS IS REPORT 2 OF 2. THE IIPV OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 1. THE PROGRAMMED FILL VOLUME WAS 2400ML. THE DRAIN VOLUME WAS 4268ML. THIS 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 83 YR