BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1850626 · Received October 1, 2010

    Report

    Report Number
    1423500-2010-04005
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. THE ROOT CAUSE WAS RELATED TO THE PATIENT BEGINNING THERAPY PRIOR TO CONNECTING. DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A SAMPLE WAS NOT REQUESTED. A LABELING REVIEW WAS PERFORMED AND FOUND TO BE ADEQUATED. THE HOME PATIENT'S NURSE WAS ADVISED OF THIS REPORT AND INDICATED SHE WOULD REVIEW PROPER PROCEDURES WITH THE PATIENT. NO PATIENT INJURY WAS REPORTED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A HOME CHOICE USE ERROR, AS THE HOME PATIENT (HP) WAS IN INITIAL DRAIN AND NOT CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE HP TO END THERAPY AND ADVISED THE HP TO START OVER AGAIN USING NEW SUPPLIES. THERE WAS NO ALARM ON THE HOMECHOICE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR