BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1840501 · Received September 21, 2010

    Report

    Report Number
    1423500-2010-03600
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    April 24, 2010
    Report Date
    August 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE PATIENT'S DRAIN VOLUME WAS 3798ML. THE FILL VOLUME WAS 2300ML. THIS MEETS INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2011 REGARDING THE IIPV EVENT. ACCORDING TO THE NURSE SHE WAS NOT AWARE OF THE IIPV EVENT. ADDITIONALLY, THE PATIENT HAS NEVER REPORTED ANY SYMPTOMS OF OVERFILL. THE PATIENT HAS SINCE TRANSFERRED TO HEMODIALYSIS, HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE. EVALUATION SUMMARY: THE PRODUCT ANALYSIS LAB EVALUATED THE DEVICE. THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE IIPV THAT WAS DISCOVERED DURING EVALUATION. BASED ON A REVIEW OF ALL AVAILABLE THERAPY LOG DATA THE PROBABLE CAUSE WAS DETERMINED TO BE INSUFFICIENT DRAIN- USE ERROR; TIDAL ULTRAFILTRATION REMOVAL SET TOO LOW. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. LABELING REVIEW FOUND LABELING TO BE SUFFICIENT FOR THE USE ERROR IDENTIFIED IN THIS REPORT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED BUT NOT YET COMPLETED. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP EMDR.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A HOMECHOICE DEVICE, AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON DATE (B)(6) 2010, DURING DRAIN CYCLE 5. THE ULTRAFILTRATION (UF) VOLUME WAS 1613 ML. THE DRAIN VOLUME WAS 3798 ML. THIS EVENT MEETS OVERFILL CRITERIA.

    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 24 YR