BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV NITRO PLUM SET

    MDR report key: 423552 · Received October 18, 2002

    Report

    Report Number
    9615050-2001-00012
    Event Type
    Malfunction
    Date Received
    October 18, 2002
    Date of Event
    April 1, 2001
    Report Date
    April 18, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTS REC'D OF AN UNDOCUMENTED NUMBER OF UNDOCUMENTED INCIDENTS OF PROXIMAL OCCLUSION ALARMS. THE CUSTOMER STATES THAT THE PROXIMAL OCCLUSION ALARMS WERE OCCURRING SET-UP. THE ALARMS ARE OCCURRING IN THE EMERGENCY ROOM AND CORONARY CARE UNITS WHEN A NITROGLYCERIN (NTG) DRIP WAS TO BE INITIATED. THE NITROGLYCERIN WAS TO BE INFUSED FOR PAIN RELIEF ON ADULT CARDIAC PTS. UNSPECIFIED NUMBER OF THE PTS WERE HAVING ACUTE MYOCARDIAL INFARCTIONS. THE CUSTOMER REPORTS THERE WERE TWO INCIDENTS ON TWO ACUTE MYOCARDIAL INFARCTION PTS WHERE THE NTG DRIP WAS DELAYED UP TO 30 MINUTES. THE TUBING SET WAS CHANGED FOUR TIMES AND THEN THE STAFF USED A REGULAR PLUM TUBING SET TO INFUSE THE NTG DRIP. THE PTS PAIN LEVEL DID NOT INCREASE DURING THE DELAY. MORPHINE WAS ADMINISTERED IV TO ASSIST WITH PAIN RELIEF. THE PTS CONDITION REMAINED STABLE. NO REPORT OF ADVERSE PT EFFECT. ADD'L PT INFO WAS REQUESTED, BUT NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NV NITRO PLUM SET ADMINISTRATION SET FPA ABBOTT LABORATORIES NA 64-015-5H

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other LIFECARE 5000 PUMPS. SERIAL NUMBER UNSPECIFIED.