BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

    MDR report key: 1802242 · Received August 17, 2010

    Report

    Report Number
    1423500-2010-02574
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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). DEVICE EVALUATION EXPECTED, BUT NOT YET COMPLETED. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP MDR.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED AND DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS. THE PRODUCT ANALYSIS LAB EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY IIPV FOUND IN THE DEVICE LOGS. THE CAUSE OF THE IIPV WAS DETERMINED TO BE: INAPPROPRIATE BYPASS OF THE LOW DRAIN VOLUME ALARM. PRODUCT SURVEILLANCE FOLLOWED UP WITH THE NURSE AND PROVIDED THE RESULTS OF EVALUATION. THE NURSE STATED THAT THE PATIENT WAS DOING WELL ON THE NEW CYCLER. THE NURSE STATED THAT SHE WOULD FOLLOW UP WITH THE PATIENT TO MAKE SURE THEY UNDERSTOOD NOT TO PERFORM BYPASS. THE NURSE CONFIRMED THAT NO MEDICAL INTERVENTION OR PATIENT INJURY WAS REPORTED. THE DEVICE WAS SUBSEQUENTLY FORWARDED TO SERVICE. 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 DEVICE, AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WAS IDENTIFIED WHICH OCCURRED ON DATE (B)(6) 2010 DURING DRAIN CYCLE 9. THE DRAIN VOLUME WAS 3637 MILLILITERS (ML). THE PROGRAMMED FILL VOLUME WAS 2200ML. THIS DRAIN VOLUME MEETS OVERFILL CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ATRIAL OVERSENSING OCCURRED DUE TO EXTERNAL INTERFERENCE WHICH RESULTED IN AN AUTO MODE SWITCHING EPISODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1