BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CURLIN 6000CMS

    MDR report key: 23436192 · Received October 31, 2025

    Report

    Report Number
    MW5178332
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 10, 2025
    Report Date
    October 25, 2025
    Manufacturer
    MOOG COSTA RICA, SRL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) HOME HEALTH RN REPORTED THEY ARE IN PT'S HOME DOING DAY 1 INFUSION NOW AND IS HAVING ISSUES WITH CURLIN PUMP, WHICH IS STILL NOT RESOLVED BY MOOG WHEN NURSE SPOKE WITH THEM. HOME HEALTH NURSE IS FINISHING INFUSION VIA GRAVITY TODAY, BUT WILL NEED NEW PUMP FOR DAY 2 INFUSION TOMORROW. 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: PRIVIGEN SDV - 30GM. PRIVIGEN SDV INDICATION: MYASTHENIA GRAVIS WITHOUT (ACUTE) EXACERBATION. 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
    2085665 PUMP CURLIN 6000CMS PUMP, INFUSION FRN MOOG COSTA RICA, SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female