BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2001870 · Received February 25, 2011

    Report

    Report Number
    1423500-2011-02461
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    December 29, 2010
    Report Date
    February 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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). EVALUATION SUMMARY: THE PRODUCT ANALYSIS LAB EVALUATED THE DEVICE AND FOUND AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT DURING EVALUATION. BASED ON A REVIEW OF ALL AVAILABLE THERAPY LOG DATA, THE CAUSE OF THE IIPV WAS DETERMINED TO BE INSUFFICIENT DRAIN / USE ERROR AS THE TIDAL ULTRAFILTRATION REMOVAL WAS SET TOO LOW. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE IIPV. LABELING REVIEW FOUND LABELING TO BE ADEQUATE FOR THE USER 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). THE DEVICE HAS BEEN RECEIVED BY BAXTER, HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 5. THE PATIENT'S ULTRAFILTRATION READING WAS 1069ML, INDICATING THE HOME PATIENT (HP) DRAINED 1069ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 1500ML. THIS INFORMATION MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2011. ACCORDING TO THE NURSE THE PATIENT DID NOT REPORT ANY SYMPTOMS OF OVERFILL. ADDITIONALLY, THE PATIENT HAS BEEN TO THE CLINIC SINCE THIS EVENT AND HAS RESUMED THERAPY WITH NO FURTHER ISSUES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR