BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1862297 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04213
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT REGARDING THE REPORTED CONDITION. THE HOME PATIENT STATED HE IS NO LONGER USING BAXTER PRODUCTS. THE SAMPLE WAS DISCARDED. THE HOME PATIENT DID NOT PROVIDE ANY ADDITIONAL INFORMATION. THE ROOT CAUSE OF THE CHECK HEATER LINE ALARM WAS UNDETERMINED. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A CHECK HEATER LINE ALARM, WHICH OCCURRED ON THE HOMECHOICE DURING FILL 1 OF 5. THE HOME PATIENT (HP) STATED HE HAS PROBLEMS WITH THE BAGS BEING SEALED CLOSED AT THE PORTS. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THAT THE BAG AND CASSETTE WILL NEED TO BE REPLACED. THE HP STATED HE WOULD START OVER WITH NEW SUPPLIES AND CALL BACK WITH ANY QUESTIONS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INITIAL CALL.

    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 97 YR