BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2120557 · Received June 10, 2011

    Report

    Report Number
    1423500-2011-07442
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 21, 2011
    Report Date
    May 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    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 REPORTED MANUAL EXCHANGE OF 2000 ML AND THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) OF 3554 ML COULD NOT BE DETERMINED. THE DEVICE WAS NOT RETURNED TO BAXTER, PRECLUDING FURTHER DEVICE INVESTIGATION. REVIEW OF THE PREVIOUS SERVICE RECORD REVEALED NO ISSUES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. A CAUSE OF THE REPORTED DIFFICULTY COULD NOT BE DETERMINED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH A CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE HOME PATIENT (HP) REPORTED A DRAIN VOLUME OF 3554ML IN DRAIN 2 OF 3. THE FILL VOLUME IS 2000ML AND THE LAST FILL VOLUME IS 500ML. 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 60 YR