BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CURLIN 6000CMS

    MDR report key: 23368493 · Received October 23, 2025

    Report

    Report Number
    MW5177889
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 18, 2025
    Manufacturer
    MOOG COSTA RICA, SRL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PT REPORTED INFUSION NURSE IS ABOUT TO DO INFUSION AND PT'S CURLIN PUMP IS READING SYSTEM TIMEOUT. NEW PUMP WILL BE SENT AS CURRENT PUMP CANNOT BE USED. INFUSION NURSE REPORTED THEY WILL REPROGRAM PT'S WIFE'S CURLING PUMP TO PT'S PROGRAM AND THEN SWITCH BACK TO PT'S WIFE'S PROGRAM ONCE INFUSION IS COMPLETE. 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: GAMUNEX-C 10% SDV - 40GM. GAMUNEX-C 10% SDV INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. DID PT 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
    1611879 PUMP CURLIN 6000CMS PUMP, INFUSION FRN MOOG COSTA RICA, SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male GAMUNEX-C 10% SDV (40GM/400ML).