BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CURLIN 6000CMS

    MDR report key: 23436065 · Received October 31, 2025

    Report

    Report Number
    MW5178325
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 5, 2025
    Report Date
    October 24, 2025
    Manufacturer
    MOOG COSTA RICA, SRL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED REGISTERED NURSE COULD NOT INFUSE MEDICATION YESTERDAY DUE TO PUMP READING SYSTEM TIMEOUT. REGISTERED NURSE INFUSED MANUALLY. PUMP SERIAL NUMBER AND EXPIRATION UNKNOWN. NO FURTHER INFORMATION, DETAILS OR DATES AVAILABLE. PRODUCT LOT AND EXPIRATION UNKNOWN. UNKNOWN IF MD IS AWARE. DOSE/AMOUNT: GAMMAGARD LIQ SOLN - 45GM. GAMMAGARD LIQ SOLN INDICATION: LUNG TRANSPLANT REJECTION; LUNG TRANSPLANT STATUS; LONG TERM (CURRENT) USE OF IMMUNOSUPPRESSANT. DID PATIENT MISS A DOSE OR HAVE AN INTERRUPTION TO THERAPY? - UNKNOWN. DID ADVERSE EVENT(S) RESULT DUE TO PRODUCT ISSUE? - UNKNOWN. DID PHARMACY REPLACE DEVICE? - YES. IS DEVICE ASSOCIATED WITH EVENT AVAILABLE FOR RETURN? - UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714938 PUMP CURLIN 6000CMS PUMP, INFUSION FRN MOOG COSTA RICA, SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female GAMMAGARD LIQ SOLN.