BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3864290 · Received June 10, 2014

    Report

    Report Number
    1416980-2014-18613
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 17, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. PER ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿, USERS ARE NOT INSTRUCTED TO DISCONNECT DURING THERAPY UNLESS FOR AN EMERGENCY DISCONNECT PROCEDURE. THE PATIENT GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR RETURNING TO THERAPY AFTER THE EMERGENCY DISCONNECT PROCEDURE. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240 (AIR IN SET) ALARM OCCURRED DURING THE DRAIN EIGHT OF EIGHT ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE EVENT. THE HP STATED THEY HAD DISCONNECTED FROM THE PATIENT LINE AND HAD SUBSEQUENTLY RECONNECTED TO THE PATIENT LINE. 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
    338619 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR HOMECHOICE