BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL NON-DEHP SOLUTION SET W/1.2M AIR ELIMINATING FILTER

    MDR report key: 1940008 · Received December 28, 2010

    Report

    Report Number
    6000001-2010-06280
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 3, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K952074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED NOR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. 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). IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN TO BAXTER AN UNKNOWN NUMBER OF FLO GARD INFUSION PUMPS WHICH WAS INVOLVED IN AN INCIDENT WHERE OCCLUSIONS WERE CAUSED BY THE CLEARLINK NON-DEHP SOLUTION SET WITH 1.2 M AIR ELIMINATING FILTER WHILE BEING USED WITH CLEAR TPN. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL NON-DEHP SOLUTION SET W/1.2M AIR ELIMINATING FILTER SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 FLOGARD PUMP| CLEAR TOTAL PARENTERAL NUTRITION