BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED SOLUTION SET

    MDR report key: 1902358 · Received November 18, 2010

    Report

    Report Number
    6000001-2010-04963
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. A VISUAL EXAMINATION OF THE SAMPLE CONFIRMED THE PRESENCE OF KINKS IN THE TUBE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE ROOT CAUSE OF THIS CONDITION WAS ATTRIBUTED TO INADEQUATE COILING OF THE UNIT DURING PACKAGING (RADIUS OF CURVATURE IS TOO SMALL FOR TUBE DIMENSION AND MATERIAL). BAXTER IS STANDARDIZING AND IMPROVING THE COILING METHOD FOR ALL CODES BY INSTALLING AN AUTOMATIC COILER. THIS PROJECT IS IN PROGRESS AND UNTIL ITS COMPLETION, A 100% VISUAL CHECK OF THE UNITS BEFORE BEING PACKED IS PERFORMED. ALSO, THE RELAY OUT OF THE PACKAGING AREA WAS COMPLETED TO IMPROVE THE VISUAL CONTROL OF THE UNITS BEFORE BEING PLACED IN THE CARTON BOXES. BAXTER IS MONITORING THE TREND OF THE REPORTED ISSUES DURING THE QUALITY REVIEWS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A VENTED SOLUTION SET THAT HAD KINKED TUBING WHICH OBSTRUCTED FLOW. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. ONE UNIT WAS IMPACTED, AND RETURNED FOR EVALUATION. NO OTHER INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10E16V347M

    Patients

    Seq Age Sex Outcome Treatment
    1