BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1920499 · Received December 12, 2010

    Report

    Report Number
    1423500-2010-06811
    Event Type
    Malfunction
    Date Received
    December 12, 2010
    Date of Event
    November 20, 2010
    Report Date
    November 20, 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). THE SAMPLE LOT NUMBER IS UNKNOWN AT THIS TIME. THE SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS REPORT OF A CHECK PATIENT LINE WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. A BATCH REVIEW WAS NOT PERFORMED AS LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE 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 CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC) MACHINE. PER THE INITIAL REPORT, THE HOME PATIENT (HP) REPORTED A CHECK PATIENT LINE ALARM IN THE INITIAL DRAIN. THE HP STATED SHE NOTICED THAT THERE WAS AIR IN THE PATIENT LINE AND KNEW SHE NEEDED TO START OVER WITH NEW SUPPLIES, BUT NEEDED ASSISTANCE ENDING THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) WALKED THE HP THROUGH THE ENDING THERAPY EARLY PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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