BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2033237 · Received March 30, 2011

    Report

    Report Number
    1423500-2011-03826
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 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, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BASED ON A REVIEW OF ALL AVAILABLE THERAPY LOG DATA, THE CAUSE OF THE IIPV WAS DETERMINED TO BE: INSUFFICIENT DRAIN, ONE OR MORE CYCLES ADVANCES TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. 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 (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 ON (B)(6) 2011 DURING DRAIN CYCLE 4. THE PATIENT'S ULTRAFILTRATION READING WAS 128ML, INDICATING THE HOME PATIENT (HP) DRAINED 128ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 410ML. THIS INFORMATION MEETS IIPV CRITERIA. ON (B)(6) 2011, BAXTER PRODUCT SURVEILLANCE SPOKE WITH THE PERITONEAL DIALYSIS NURSE REGARDING THE IIPV EVENT. THE NURSE STATED THE PATIENT DID NOT HAVE ANY SYMPTOMS AROUND THE TIME OF THE INCIDENT. THE PATIENT IS FINE AND CONTINUING THERAPY ON THE CYCLER WITH NO ISSUES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    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 3 YR