BEUDAMED
    FDA Adverse Event Summary report: N

    ARROW BLUEGARD

    MDR report key: 1936205 · Received December 9, 2010

    Report

    Report Number
    1936205
    Date Received
    December 9, 2010
    Date of Event
    February 23, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    DQY
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WASHED WITH CHLORHEXIDINE WASH EVENING BEFORE AND EXPERIENCED ITCHING WITH A RASH. SELF-TREATED WITH BENADRYL AND PRESENTED TO PREOP THE FOLLOWING MORNING. REACTION TO THE WASH WAS EXPLAINED TO THE NURSE AND AN "ALLERGY" WAS RECORDED. THE USUAL ORAL RINSE WITH CHLORHEXIDINE GLUCONATE 0.12% WAS COMPLETED. FORTY-FIVE MINUTES LATER A CENTRAL LINE WAS INSERTED IN PREPARATION FOR THE CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE. SHORTLY THEREAFTER THE PATIENT EXPERIENCED SHORTNESS OF BREATH, AND DEMONSTRATED "SEIZURE-LIKE" MOVEMENT. HE WAS INTUBATED TO PROTECT HIS AIRWAY AND SURGERY WAS CANCELLED. IN ADDITION TO THE CENTRAL LINE AND ORAL RINSE, STAFF UTILIZED CHLORHEXIDINE HAND GEL THROUGHOUT THEIR CONTACT WITH THE PATIENT WHILE PREPPING HIM FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW BLUEGARD ARROWGARD BLUE TRIPLE LUMEN CENTRAL LINE CATHETER DQY ARROW INTERNATIONAL * RF8123993

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR OTHER