BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3923731 · Received July 9, 2014

    Report

    Report Number
    1416980-2014-21970
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED, A SAMPLE EVALUATION COULD NOT BE COMPLETED. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) FELT OVERFILLED DURING DWELL ONE OF FOUR ON THE HOME CHOICE (HC). THE CALLER STATED THE MANUAL DRAIN VOLUME EQUALED 3450ML AND THE FILL VOLUME (FV) EQUALED 1800ML. THE HOME PATIENT (HP) STATED THEY HAD PERFORMED A MANUAL EXCHANGE PREVIOUSLY. THE HP INDICATED THEY HAD MANUALLY FILLED WITH 2000ML. THE INITIAL DRAIN ALARM EQUALED 0ML. THE HP INDICATED THEY WOULD END THERAPY FOR THE EVENING. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400803 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1