BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1901184 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05854
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 9, 2010
    Report Date
    October 25, 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). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. 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). DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE AN ISSUE OF IIPV WAS DISCOVERED. THERAPY STARTED DATE (B)(6) 2010 / CYCLE 2/ 1584 ML UF WAS CONFIRMED IN THE LOGS, BUT NOT DUPLICATED DURING PAL EVALUATION. THE ROOT CAUSE 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. A REVIEW OF THE PREVIOUS SERVICE RECORD SHOWS THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE FROM THE TAMPA BAY FACILITY. NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE DIFFICULTY OF IIPV-ADULT. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IDENTIFIED DURING THIS INVESTIGATION. 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

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE MACHINE, A BAXTER TECHNICIAN FOUND AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WHICH OCCURRED ON (B)(6) 2010, DURING DRAIN CYCLE 2. THE ULTRAFILTRATION VOLUME WAS 1584ML. THIS EVENT MEETS OVERFILL CRITERIA. ON (B)(6) 2010, PRODUCT SURVEILLANCE SPOKE WITH THE NURSE AND PROVIDED THE RESULTS OF THE EVALUATION AND THE PROBABLE CAUSE IDENTIFIED. THE NURSE STATED THAT THE PATIENT WAS HAVING SOME INTERNAL CATHETER ISSUES, WHICH THE DOCTOR ADDRESSED. THE NURSE STATED THAT THERE WAS NO MEDICAL INTERVENTION OR PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    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 58 YR