BEUDAMED
    FDA Adverse Event Other Summary report: N

    MOOG CURLIN INFUSION

    MDR report key: 2133469 · Received June 14, 2011

    Report

    Report Number
    MW5021012
    Event Type
    Other
    Date Received
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    MOOG MEDICAL SERVICES GROUP
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE MOOG CURLIN PUMP (B)(4) WITH A BATTERY DOOR (B)(4). THE DESIGN OF THE DOOR HAS A SLIDE CLAMP TO LOCK THE BATTERY DOOR IN PLACE AND PREVENT THE BATTERIES FROM FALLING OUT OF THE INFUSION PUMP. THE (B)(4) PUMP IS USED ON PEDIATRIC PTS GETTING TOTAL PARENTERAL NUTRITION, HYDRATION, IVIG ANTIBIOTICS, CHEMOTHERAPY OR PAIN MGMT. THE LOSS OF BATTERY COVER PREVENTS THE PUMP FROM OPERATING CORRECTLY AND CAUSING THE INFUSION TO STOP AND DEVICE MALFUNCTION. THERE HAVE BEEN MULTIPLE DEFECTIVE DOORS WITH INTERRUPTION IN THERAPY BUT NO CURRENT HARM. THERE IS A DESIGN FAILURE WHERE THE SLIDE CLAMP SEPARATES FALLS OFF AND THE DOOR NO LONGER FUNCTIONS CORRECTLY. MULTIPLE BATTERY DOORS HAVE BEEN RETURNED TO THE MFR WITH NO REPLY OF CORRECTION PLAN. CURRENTLY, AN ADD'L 11 BROKEN BATTERY DOORS IN POSSESSION. DATES OF USE: (B)(6) 2011. THE DOOR WAS REDESIGNED BUT THE NEW DESIGN IS DEFECTIVE LEADING TO MANY DOOR REPLACEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOOG CURLIN INFUSION CURLIN CMS 4000 LZH MOOG MEDICAL SERVICES GROUP CMS 4000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other