BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLUTION SET WITH CONTROL-A-FLO REGULATOR

    MDR report key: 210081 · Received February 10, 1999

    Report

    Report Number
    6000001-1999-00036
    Event Type
    Malfunction
    Date Received
    February 10, 1999
    Date of Event
    January 1, 1999
    Report Date
    January 21, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTS ONE INCIDENT IN WHICH THE PT BECAME BRADYCARDIC, (HEART RATE OF 30). HEALTH CARE PROFESSIONAL ATTEMPTED TO ADMINISTER PUSH MEDICATION OF ATROPHINE ABOVE THE REGULATOR, HOWEVER, WAS UNABLE TO ADMINISTER. HEALTH CARE PROFESSIONAL ATTEMPTED TO REGULATE THE CAF REGULATOR, AND THE REGULATOR HAD "FROZE". HEALTH CARE PROFESSIONAL THEN INJECTED BOLUS OF MEDICATION INTO Y-SITE BELOW THE REGULATOR. PT WAS TRANSFERRED TO INTENSIVE CARE UNIT UNTIL STABLE. AFTER SET CHANGE HAD BEEN CONDUCTED. HEALTH CARE PROFESSIONAL STATED HE HAD A PAIR OF SURGICAL GLOVES ON AND TURNED AND REGULATOR AS HARD AS HE COULD UNTIL IT FINALLY GAVE WAY AND TURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINU-FLO SOLUTION SET WITH CONTROL-A-FLO REGULATOR CONTINUE-FLO SET FPA BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN