BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CURLIN 6000CMS

    MDR report key: 23350936 · Received October 21, 2025

    Report

    Report Number
    MW5177759
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Report Date
    October 16, 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

    PATIENT (PT) REPORTED THEIR HOME HEALTH REGISTERED NURSE (RN) STATED PATIENT (PT) NEEDS A NEW PUMP DUE TO CURRENT PUMP READING A BATTERY ERROR. PUMP SERIAL NUMBER AND EXPIRATION UNKNOWN. NO FURTHER INFORMATION, DETAILS OR DATES AVAILABLE. PRODUCT LOT AND EXPIRATION UNKNOWN. UNKNOWN IF MEDICAL DOCTOR (MD) IS AWARE. DOSE/AMOUNT: PRIVIGEN SDV - 35GM. PRIVIGEN SINGLE-DOSE VIALS (SDV) INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED; NONFAMILIAL HYPOGAMMAGLOBULINEMIA. 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
    2730417 PUMP CURLIN 6000CMS PUMP, INFUSION FRN MOOG COSTA RICA, SRL 00000036299

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female PRIVIGEN SDV--.