BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1884473 · Received October 28, 2010

    Report

    Report Number
    1423500-2010-05003
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS NOT RETURNED TO BAXTER, PRECLUDING FURTHER DEVICE INVESTIGATION. AS A RESULT, AN ASSIGNABLE CAUSE OF THE REPORTED DIFFICULTY COULD NOT BE DETERMINED. AS A RESULT OF THIS INCIDENT, THE BAXTER TECHNICAL SERVICE REPRESENTATIVE INSTRUCTED THE CAREGIVER TO ADJUST THE INITIAL DRAIN ALARM SETPOINT AS NEEDED WHEN THE DEVICE DISPLAYED VERIFY I-DRAIN = 0ML. RENAL QUALITY ENGINEERING, ALONG WITH PLANT SERVICING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. 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

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT THE HOME PATIENT (HP) ONLY DRAINED 3ML IN THE INITIAL DRAIN. THE HC WAS IN DWELL AND THE HP WAS FEELING VERY TIGHT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP PRESS STOP THEN ARROW DOWN AND START A MANUAL DRAIN. THE HP WAS SITTING UP AND DRAINED 3665ML, FILL VOLUME 200ML, LAST FILL VOLUME 2000ML, INITIAL DRAIN ALARM 0ML. THE TSR ADVISED WHEN THEN HC DISPLAYS VERIFY I-DRAIN 0ML THAT IT NEEDS TO BE ADJUSTED ACCORDINGLY. THE TSR ASSISTED THE CAREGIVER (CG) WITH THE ENDING THERAPY EARLY PROCEDURE. THE CG WILL NOTIFY THE PERITONEAL DIALYSIS NURSE IN THE MORNING. THE CG REFUSED A SWAP OF THE DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2010 PRODUCT SURVEILLANCE CONTACTED THE HP PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORT OF FEELING TIGHT WITH A HIGH DRAIN VOLUME. THE PDN VERIFIED THE HP'S LARGEST PRESCRIBED FILL VOLUME (LPFV) IS 2200ML AND 5 CYCLES. THE PDN STATED THE HP HAS NOT REPORTED ANY SYMPTOMS OR OTHER DRAIN VOLUMES THAT MEET INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA. THE PDN CONFIRMED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT AND THAT THE HP WAS DOING WELL WITH THE FOLLOWING TREATMENTS.

    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 66 YR