BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS50 INFUSION PUMP

    MDR report key: 1003867 · Received February 14, 2008

    Report

    Report Number
    6000001-2008-00050
    Event Type
    Injury
    Date Received
    February 14, 2008
    Date of Event
    December 12, 2007
    Report Date
    February 5, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    k961225
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE REC'D FOR EVAL, A F/U REPORT WILL BE FILED UPON COMPLETION OF AN EVAL OR IF ANY ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A VOLUNTARY MEDWATCH WAS REC'D BY BAXTER HEALTHCARE AND INDICATES THAT THE AS50 PUMP MALFUNCTION AND DISPLAYED AN ERROR CODE "MERE" DURING A PT INFUSION OF EPINEPHRINE (DOSE, RATE, CONCENTRATION AND VOLUME UNK). THE BLOOD PRESSURE REPORTEDLY DROPPED TO AN UNK LEVEL. IT IS UNK WHAT INTERVENTIONS WERE REQUIRED. THE EPINEPHRINE WAS REPORTEDLY RESTARTED USING ANOTHER SYRINGE PUMP. THE BLOOD PRESSURE WAS RESTORED AFTER AN UNK LENGTH OF TIME. ALTHOUGH REQUESTS HAVE BEEN MADE, NO ADD'L CLINICAL INFO HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AS50 INFUSION PUMP 80FPA FRN BAXTER HEALTHCARE PTE. LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *