BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOOG CURLIN INFUSION ADMINISTRATION SET

    MDR report key: 2000440 · Received February 17, 2011

    Report

    Report Number
    MW5019485
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ZEVEX, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT ON A CURLIN CMS 4000 INFUSION PUMP EXPERIENCED AN ALARM, SCREEN DISPLAYS "ALARM REPLACE SET 3." MOOG CURLIN ADMINISTRATION SET ((B)(4)) BECOMES DEFORMED, APPARENTLY LOSES PATENCY WHEN PUMPING FINGERS IN THE TUBING GUIDE RECEPTACLE EXERT PRESSURE ON TUBING. ATTEMPTS TO RETURN THE TUBING TO ORIGINAL SHAPE ARE INEFFECTIVE, AND ONLY REPLACEMENT OF TUBING RESOLVED THE ALARM. DATES OF USE: SEVERAL HRS ¿ (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: ANTIBIOTIC INTERMITTENT INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOOG CURLIN INFUSION ADMINISTRATION SET ADMINISTRATION SET FPA ZEVEX, INC 340-4114 CF1030901

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR