BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL

    MDR report key: 480836 · Received August 28, 2003

    Report

    Report Number
    9615050-2003-00169
    Event Type
    Death
    Date Received
    August 28, 2003
    Date of Event
    August 4, 2003
    Report Date
    August 4, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT #2 OF 2 RECEIVED OF AN INABILITY TO DELIVER DRUGS VIA SYRINGE THROUGH THE CLAVE PORT. THE NURSE REPORTED THAT THE PT ARRIVED IN THE ICU WITH AN UNKNOWN IV SOLUTION INFUSING VIA PUMP. AT AN UNSPECIFIED TIME LATER, THE PT CODED. THE NURSE REPORTEDLY ATTEMPTED TO ACCESS THE CLAVE PORT TO INFUSE AN UNSPECIFIED MEDICATION. MEETING RESISTANCE, THE NURSE REPORTEDLY REMOVED THE TUBING FROM THE PUMP AND INFUSED THE UNSPECIFIED SOLUTION VIA GRAVITY. THEY DISCONNECTED THE SECONDARY LINE FROM THE CASSETE SECONDARY PORT AND WAS ABLE TO ADMINISTER THE UNSPECIFIED MEDICATION THROUGH THE CASSETTE SECONDARY PORT. THE PT REPORTEDLY EXPIRED SHORTLY AFTER THE CODE FROM AN ACUTE MYOCARDIAL INFARCTION. THE CUSTOMER REPORTED THAT IN THEIR OPINION, "THIS INCIDENT WAS NOT A FACTOR IN THE PT'S DEATH". ALTHOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL ADMINISTRATION SET FPA ABBOTT LABORATORIES NA 050215H

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death KENDALL MONOJECT SYRINGE.| PLUM 1.6 PUMP, LIST #02507, SERIAL NUMBER UNK.