BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1901431 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05885
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 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 TO BAXTER, PRECLUDING FURTHER DEVICE INVESTIGATION. AS A RESULT, AN ASSIGNABLE CAUSE FOR THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) COULD NOT BE DETERMINED. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE IIPV. 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 (B)(4) TO REPORT A CAUTION NEGATIVE ULTRAFILTRATION (UF) ALARM IN DRAIN 3 OF 6, DRAIN VOLUME (DV) 1630ML, FILL VOLUME (FV) 2000ML, UF -896ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP REPOSITION AS THE HOME PATIENT (HP) SLEEPS IN THE RECLINER. THE TSR HAD THE CALLER PRESS STOP/GO AND THE DV INCREASED TO 3399ML AND THE HC MOVED TO FILL 4 OF 6. THE UF WAS 507ML. THE CALLER DID NOT WANT A SWAP AND WOULD SPEAK WITH THE REGISTERED NURSE (RN) REGARDING THE HIGH DRAIN VOLUME AND NEGATIVE UF ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2010 PRODUCT SURVEILLANCE RECEIVED A RETURNED CALL FROM THE HP'S PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORT OF THE HIGH DRAIN VOLUME. THE PDN VERIFIED THE LARGEST PRESCRIBED FILL VOLUME (LPFV) TO BE 2000ML. 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. A SWAP WAS NOT REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1