BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3981099 · Received August 5, 2014

    Report

    Report Number
    1416980-2014-25355
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP/GRAVITY SOLUTION SET LEAKED FROM BELOW ITS DRIP CHAMBER. AIR WAS ALSO NOTICED IN APPROXIMATELY 30 TO 40 CM OF TUBING. THIS OCCURRED DURING PATIENT INFUSION OF PARACETAMOL USING GRAVITY. THE SETUP CONSISTED OF THE SOLUTION SOURCE CONNECTED TO THE SOLUTION SET, WHICH WAS CONNECTED TO AN EXTENSION SET, WHICH WAS CONNECTED TO A CATHETER. THE INFUSION WAS THEN STOPPED, AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457424 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 14D13V231N

    Patients

    Seq Age Sex Outcome Treatment
    1 PARACETAMOL| CATHETER| EXTENSION SET