BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2002617 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02519
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    November 8, 2010
    Report Date
    February 7, 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) THAT WAS DISCOVERED DURING EVALUATION. BASED ON A REVIEW OF ALL AVAILABLE THERAPY LOG DATA, THE CAUSE OF THE IIPV WAS UNDETERMINED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE IIPV. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RTB-CAPA-(B)(4).

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED DURING THE INITIAL DRAIN. THE PATIENT'S DRAIN VOLUME 3032ML. THE FILL VOLUME WAS 1700ML. THIS MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(4) 2011. ACCORDING TO THE NURSE THE PATIENT HAS NOT REPORTED ANY SYMPTOMS OF OVERFILL. THE PATIENT RESUMED THERAPY AFTER THIS EVENT WITH NO FURTHER ISSUES. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR