BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHURCHILL MEDICAL SYSTEMS, INC. A VYCON CO.

    MDR report key: 2190810 · Received July 29, 2011

    Report

    Report Number
    MW5021580
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 29, 2011
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(4). A VYCON COMPANY, PRODUCT CODE AMS-122-1, 84" PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE FLOW REGULATOR AND MLL APPROX PRIMING VOLUME-13.08 ML 20 DROPS/ML-APPROX, LOT# 1104010 AND # 1104011. ABOVE PRODUCT (LOT# 1104011) FOUND TO BE INFUSING AT MUCH FASTER RATE THAN SET. PT IN HOME REPORTED 250 ML 0.9% NS BAG OF IV VANCOMYCIN 500 MG, SET AT 250 INFUSED OVER 20 MINUTES INSTEAD OF 1 HOUR. NURSE SENT TO HOME TO CONFIRM WITH ANOTHER TUBING, SAME LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHURCHILL MEDICAL SYSTEMS, INC. A VYCON CO. 84" PRIMARY SOLUTION SET W/UNIVERSAL SPIKE FPA CHURCHILL MEDICAL SYSTEMS, INC. AMS-122-1 1104011
    2 CHURCHILL MEDICAL SYSTEMS, INC. A VYCON COMPANY 84" PRIMARY SOLUTION SET W/UNIVERSAL SPIKE FPA CHURCHILL MEDICAL SYSTEMS, INC. AMS-122-1 1104010

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Disability