BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3873407 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-19031
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION PARTIALLY PRIMED. DURING VISUAL INSPECTION IT WAS NOTED THAT THE VENT CAP WAS OPEN AND THE SET HAD BEEN PRIMED TO THE MALE LUER. DURING FUNCTIONAL TESTING THE DEVICE WAS SPIKED INTO AN IN-HOUSE 1000 ML BAG OF DISTILLED WATER AND NORMAL FLOW WAS OBSERVED. THE REPORTED PROBLEM COULD NOT BE VERIFIED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENTED SOLUTION SET WAS DIFFICULT TO PRIME. THE USER WAS ATTEMPTING TO PRIME THE SET WITH INTRAVENOUS IMMUNOGLOBULIN. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349703 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR13H30021

    Patients

    Seq Age Sex Outcome Treatment
    1