BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM MONITORING SET

    MDR report key: 272274 · Received March 30, 2000

    Report

    Report Number
    1713468-2000-00018
    Event Type
    Malfunction
    Date Received
    March 30, 2000
    Date of Event
    March 7, 2000
    Report Date
    March 7, 2000
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    KRK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LEAK OF PRESSURE MONITORING KIT REPORTED. A PT WAS HOOKED UP TO A PRESSURE MONITORING KIT AND A CARDIAC CATHETERIZATION PROCEDURE STARTED. THE TUBING LEAKED WHEN INJECTOR USE WAS STARTED. A BLISTER WAS NOTED IN THE TUBING AT THE FEMALE END OF THE TUBING WHERE THEY ATTACH TO AN INJECTOR OR SYRINGE. THERE WAS NO REPORT OF BLEEDBACK OR BLOOD LOSS. A CLINICIAN REPORTED THAT ST SEGMENT ELEVATION OCCURRED AS IF AIR HAD BEEN INJECTED INTO THE PT, BUT NO AIR WAS NOTED ON FLUOROSCOPY. AN UNSPECIFIED DOSE OF NITROGLYCERIN WAS STARTED AND THE ST SEGMENT RETURNED TO A MORE NORMAL RANGE. THE TUBING WAS CHANGED TO SOLVE THE PROBLEM. NO ADVERSE SEQUELAE TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM MONITORING SET HIGH PRESSURE TUBING KRK ABBOTT LABORATORIES NA 61-080-SN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention