BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1834244 · Received September 14, 2010

    Report

    Report Number
    1423500-2010-03409
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    February 27, 2010
    Report Date
    August 23, 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 WAS RECEIVED INOPERATIVE DUE TO A SYSTEM ERROR (SE) 2390 ALARM. THE SE 2390 ALARM WAS UNABLE TO BE CLEARED AND AS A RESULT, THE HOMECHOICE RETURN INSTRUMENT TEST/EVALUATION(RITE) FUNCTIONAL AND ELECTRICAL TESTS WERE UNABLE TO BE PERFORMED. THE DEVICE WAS POWERED ON IN TEST MODE TO DOWN LOAD THE DEVICE LOGS, WHICH LOGGED THE RITE ENCOUNTERED SE 2390 ALARMS. REVIEW OF THE LOGS REVEALED SE 2390 ALARM HAD NOT OCCURRED WHILE THE DEVICE WAS IN THE CUSTOMER?S POSSESSION. CONTINUED REVIEW OF THE DEVICE LOGS REVEALED 6 INSTANCES OF DRAIN VOLUMES MEETING INCREASED INTRAPERITONEAL VOLUME (IIPV) HAD OCCURRED. INTERNAL INSPECTION OF THE DEVICE REVEALED AN ADDITIONAL DIFFICULTY OF BUG INFESTATION. THE CAUSE FOR THE 6 ADDITIONAL IIPVS WAS DETERMINED TO BE: INSUFFICIENT DRAIN. USE ERROR, TIDAL UF REMOVAL SET TOO LOW. A SERVICE HISTORY REVIEW REVEALED NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE ISSUES OF IIPV?S. A LABELING REVIEW FOUND THE LABELING TO BE SUFFICIENT. AS A RESULT OF THE BUG INFESTATION, THE DEVICE WILL BE SCRAPPED. 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 INFORMATION: THE DEVICE WAS RETURNED TO BAXTER AS A RESULT OF THE HOME PATIENT SWITCHING TO HEMODIALYSIS THERAPY.

    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

    SIX INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WERE IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE (HC) DEVICE. THIS IS REPORT 4 OF 6. THE IIPV OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 4. THE PROGRAMMED FILL VOLUME WAS 2500ML AND THE DRAIN VOLUME WAS 4568ML. THIS DRAIN VOLUME MEETS BAXTER'S IIPV CRITERIA.

    Description of Event or Problem · 1

    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 69 YR