BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV NITRO PLUM SET

    MDR report key: 326800 · Received April 6, 2001

    Report

    Report Number
    6000096-2001-00023
    Event Type
    Malfunction
    Date Received
    April 6, 2001
    Date of Event
    March 9, 2001
    Report Date
    March 9, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM ABBOTT INTERNATIONAL (ABBOTT CANADA) THAT STATES THERE WERE PROXIMAL OCCLUSION ALARMS IN THE ICU. THE REPORT STATES, "AN ICU CLINICIAN SET UP A NITROGLYCERIN (NTG) PLUM IV SET, PLACED IN THE PUMP AND THE PROXIMAL ALARM SOUNDED. THE CLINICIAN THEN SET UP ANOTHER NTG PLUM IV SET WITH THE SAME RESULTS. THE NTG DRIP HAD BEEN DELAYED 15 MINUTES AT THIS TIME. THE CLINICIAN THEN USED A PLAIN IV PLUM SET TO ADMINISTER THE NTG DRIP." IT WAS ALSO REPORTED THAT THE EMERGENCY ROOM HAD FOUR INCIDENCES OF PROXIMAL OCCLUSION ALARMS THE SAME DAY. NO FURTHER INFO COULD BE OBTAINED FROM THE CUSTOMER. NO REPORT OF ADVERSE PT EFFECT. ADDITIONAL PATIENT INFO WAS REQUESTED, BUT NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15507 NV NITRO PLUM SET ADMINISTRATION SET FPA ABBOTT LABORATORIES NA 68-144-4W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other UNSPECIFIED PLUM PUMP, SERIAL NUMBER UNKNOWN.