BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3962841 · Received July 29, 2014

    Report

    Report Number
    1416980-2014-24526
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS AN ADULT. (B)(6). AS THE SAMPLE WAS DISCARDED BY THE CUSTOMER AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLO-GARD IV SOLUTION ADMINISTRATION SET LEAKED AN UNKNOWN DRUG FROM BELOW ITS DRIP CHAMBER, CLOSE TO THE CONNECTION POINT OF THE CHAMBER AND TUBING. THIS OCCURRED DURING PATIENT INFUSION USING AN UNKNOWN INFUSION PUMP AND UNKNOWN POWER INJECTOR. THERE WAS NO REPORT OF 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
    441698 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN POWER INJECTOR| UNKNOWN INFUSION PUMP