BEUDAMED
    FDA Adverse Event Death Summary report: N

    PSI KIT: 8.5 FR X 4-1/8IN (10 CM)

    MDR report key: 1234717 · Received November 14, 2008

    Report

    Report Number
    1036844-2008-00239
    Event Type
    Death
    Date Received
    November 14, 2008
    Date of Event
    October 18, 2008
    Report Date
    November 14, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYG
    PMA / PMN Number
    k781846
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE INFO WAS REC'D BY MEDWATCH REPORT. IT WAS REPORTED THAT THE PROCEDURE WAS BEING PERFORMED ON A MALE PT WITH DIABETES AND CORONARY HEART DISEASE. THE REPORT STATES: A CARDIOVASCULAR INTENSIVE CARE UNIT PT, STATUS, POST-OPERATIVE CORONARY ARTERY BYPASS X3 IN 2008, EXPERIENCED A CHANGE IN PT CONDITION, NOTED ON EVENT DATE. THE NURSE FOUND THE 4-WAY STOPCOCK IN THE PULMONARY ARTERY CATHETER WAS CRACKED AND LEAKING MEDICATIONS. NURSES WERE IN THE PROCESS OF CHANGING THE CRACKED STOPCOCK WHEN THE PT CODED. ADD'L INFO THE FOLLOWING MONTH, FROM NURSE MGR STATED THAT THE AVERAGE MEDICATION USED THROUGH THESE CATHETERS IS EPINEPHRINE, SALINE, NEO-SYNEPHRINE AND PROPOFOL. HE DOES NOT KNOW THE EXACT DRUGS USED ON THIS PT. HE ALSO STATED THEY DO NOT USE ANYTHING TO CLEAN THE STOPCOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI KIT: 8.5 FR X 4-1/8IN (10 CM) CRITICAL CARE PSI PRODUCTS DYG ARROW INTL., INC. * RL8077862

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death