BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2082166 · Received May 9, 2011

    Report

    Report Number
    6000001-2011-03797
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    FPA
    PMA / PMN Number
    K870940
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS FUNCTIONALLY TESTED BY PRIMING THE SET WITH WATER PER THE LABEL COPY DIRECTIONS. THE VENT ON THE DRIP CHAMBER WAS CLOSED (PER LABEL COPY) DUE TO THE REPORTED USE OF A FLEXIBLE CONTAINER DURING THE EVENT. THE SET PRIMED NORMALLY AND NO DEFECTS WERE OBSERVED. THE REPORTED CONDITION WAS NOT CONFIRMED AND NO ROOT CAUSE WAS IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. 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

    THE CUSTOMER REPORTED TO BAXTER AN INTERLINK SYSTEM SOLUTION SET WITH 15 MICRON DISC FILTER IN WHICH A NO FLOW OCCURRED. ACCORDING TO THE REPORT, THE NURSE WAS INFUSING INTRAVENOUS IMMUNOGLOBULIN (IVIG) ON A PATIENT, AND AFTER THE SECOND BOTTLE OF IVIG WAS CONNECTED, THE FLOW SLOWED TO A STOP AND THEY THINK EITHER THE FILTER BECAME CLOGGED OR THE VENT BECAME CLOGGED. THE SET WAS SWAPPED OUT AND THIS CONDITION OCCURRED TWO MORE TIMES. THE REPORTER STATED THAT THREE SETS WERE USED IN TOTAL FOR THE SAME PATIENT THAT REQUIRED A LOT OF IVIG. THE CONDITION OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS IS REPORT 1 OF 3 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - CLEVELAND GD878835

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRAVENOUS IMMUNOGLOBULIN (IVIG)