BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2033225 · Received March 30, 2011

    Report

    Report Number
    1423500-2011-03824
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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). THE CUSTOMER'S REPORTED DRAIN VOLUME OF 4771ML FOR THE PROGRAMMED FILL VOLUME OF 2800ML, MET THE INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA. REVIEW OF THE PREVIOUS SERVICE RECORD REVEALED NO ISSUES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE DEVICE WAS NOT RETURNED TO BAXTER, PRECLUDING FURTHER DEVICE INVESTIGATION. A CAUSE OF THE REPORTED DIFFICULTY OF AN IIPV COULD NOT BE DETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE HOME PATIENT (HP) STATED SHE WAS CRAMPING AND EMPTY AND WANTED TO BYPASS TO LAST FILL. THE FILL VOLUME IS 2800 ML, DRAIN VOLUME 4771 ML. THE HP STATED DID NOT FEEL OVERFULL. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED IN BYPASSING TO LAST FILL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THIS EVENT MEETS OVERFILL CRITERIA.

    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 58 YR