BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1992214 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-02002
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 22, 2011
    Report Date
    January 22, 2011
    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). THE SAMPLE IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN, THEREFORE; A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM INVESTIGATION BY BAXTER, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORT HAS BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK YOUR POSITION ALARM THAT OCCURRED ON THE HOME CHOICE (HC) DURING FILL 1 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH TROUBLESHOOTING. THE HP STATED THAT THERE WAS AIR IN THE PATIENT LINE. THE TSR THEN ADVISED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR FURTHER ASSISTED THE HP THROUGH ENDING THERAPY EARLY PROCEDURE. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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 85 YR HOMECHOICE APD CYCLER (5C4471R) REFURBISHED