BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2151837 · Received July 6, 2011

    Report

    Report Number
    6000001-2011-10512
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED TO BAXTER SOUTH AFRICA AN INFUSION ADMINISTRATION SET WITH 1.2 MICRON FILTER IN WHICH THE TOTAL PARENTERAL NUTRITION FILTER KEEPS LETTING AIR THROUGH AND THE FLUID DOES NOT RUN. ACCORDING TO THE REPORT, A PATIENT WAS CONNECTED TO A COLLEAGUE PUMP WHEN THE ISSUE OCCURRED. THE CONDITION AND PERFORMANCE OF THE COLLEAGUE PUMP WAS CHECKED, AND IT PERFORMED AS EXPECTED AND ALARMED AS IT SHOULD. THE CONDITION OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE REVEALED A WHITE SOLUTION WAS PRESENT IN THE SET. THE SOLUTION WAS FLUSHED FROM THE SET WITH NO DIFFICULTIES BY CONNECTING THE SET TO AN AIR PRESSURE OF 0.56BAR. THE SET WAS THEN FUNCTIONALLY TESTED BY CONNECTING TO A VIAFLO BAG FILLED WITH SODIUM CHLORIDE, AND THE SOLUTION WAS STOPPING AT THE CHAMBER LEVEL. THE REPORTED CONDITION WAS CONFIRMED. ALTHOUGH THE CONDITION WAS CONFIRMED, THE ROOT CAUSE WAS NOT IDENTIFIED. THE NUTRIVEX FILTERS USED ON THIS CODE ARE PURCHASED FROM AN EXTERNAL SUPPLIER. THIS COMPLAINT WAS COMMUNICATED TO BAXTER SUPPLIER QUALITY TO NOTIFY THE SUPPLIER, AND THE SAMPLE WAS SENT TO THE SUPPLIER FOR FURTHER INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) AN INFUSION ADMINISTRATION SET WITH 1.2 MICRON FILTER IN WHICH THE TPN FILTER KEEPS LETTING AIR THROUGH AND THE FLUID DOES NOT RUN. ACCORDING TO THE REPORT, A PATIENT WAS CONNECTED TO A COLLEAGUE PUMP WHEN THE ISSUE OCCURRED. THE CONDITION AND PERFORMANCE OF THE COLLEAGUE PUMP WAS CHECKED, AND IT PERFORMED AS EXPECTED AND ALARMED AS IT SHOULD. THE CONDITION OCCURRED DURING PATIENT USE. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10H26V60510

    Patients

    Seq Age Sex Outcome Treatment
    1 COLLEAGUE PUMP