BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1901454 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05889
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED, AND THE CAUSE IS UNDETERMINED. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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 A CAUTION NEGATIVE ULTRAFILTRATION (UF) ALARM IN DRAIN 1 OF 5 WITH A TOTAL ULTRAFILTRATION OF -2164ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE THERAPY. THE TSR HAD THE CAREGIVER (CG) SIT THE HOME PATIENT (HP) UP AND START THE DRAIN. THE HP DRAINED 4242ML. THE TSR ASKED THE CG IF ANY DRAINS WERE BYPASSED AND THE CG STATED YES THE INITIAL DRAIN AND THE DAY DRAIN. THE TSR ADVISED THE CG TO NEVER BYPASS THE HP BEFORE CALLING BAXTER FIRST AND TO ALWAYS CALL IF THERE IS A LOW DRAIN VOLUME ALARM. THE TSR ASKED HOW THE HP WAS FEELING AND THE CG STATED THE HP FELT FINE ALL NIGHT AND WAS FINE NOW. THE HC ADVANCED TO FILL 2 OF 5 WHEN THE HP FINISHED DRAINING. THE HP WANTED TO CONTINUE ON THE HC. THE TSR RECOMMENDED THAT THE CG CALL THE RN TO LET HER KNOW WHAT HAPPENED. 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 THE HIGH DRAIN VOLUME. THE PDN VERIFIED THE HP'S LARGEST PRESCRIBED DAY FILL VOLUME IS 2500ML AND NIGHT FILL VOLUME IS 2200ML. THE PDN STATED THEY WOULD NOT HAVE ADVISED THE CG/HP TO BYPASS A LOW DRAIN VOLUME ALARM AND WOULD FOLLOW UP WITH THE CG/HP TO ADVISE NOT TO BYPASS ANY ALARM. THE PDN DID NOT REQUEST SWAP. 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. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS.

    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