BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1840038 · Received September 21, 2010

    Report

    Report Number
    1423500-2010-03572
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 28, 2010
    Report Date
    August 28, 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETE FOR THIS REPORT OF AIR. THIS REPORT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. BASED UPON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE WAS NOT DETERMINED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WILL BE PERFORMED FOR THE LOT NUMBER PROVIDED. THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CAREGIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING AIR IN LINES ON THE HOMECHOICE (HC) MACHINE DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE CG TO START OVER WITH NEW SUPPLIES. ON (B)(6) 2010 PRODUCT SURVEILLANCE FOLLOWED UP WITH THE CG VIA PHONE CALL; THE CG STATED THERE WERE NO OPEN CLAMPS ON ANY UNUSED LINES AND NO ALARMS OCCURRED. THE CG REPORTED SHE WAS ABLE TO START OVER WITH NEW SUPPLIES AND COMPLETE THE THERAPY. THE CG ALSO CONFIRMED THERE HAS BEEN NO FURTHER ISSUE RELATED TO AIR IN THE PATIENT LINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

    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 H10G16033

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR