BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3122173 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13007
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K121634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET W/CONTROL-A-FLO REGULATOR LEAKED AT THE BUILT IN TUBING CONNECTION SITE WHERE THE NEEDLESS INJECTION PORT JOINS WITH THE EXTENSION SET TUBING. THE FLUID THAT WAS BEING INFUSED WAS LACTATED RINGER'S SOLUTION. MINIMAL BLOOD WAS LOST DURING THE ISSUE AT THE CONNECTION SITE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224898 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 LACTATED RINGER'S SOLUTION