BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CURLIN 6000CMS

    MDR report key: 23368271 · Received October 23, 2025

    Report

    Report Number
    MW5177880
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Report Date
    October 18, 2025
    Manufacturer
    MOOG / ZEVEX, INC.
    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 PT'S CURLIN PUMP MALFUNCTIONED/BROKE IN THE MIDDLE OF INFUSION. PUMP WAS GIVEN SYSTEM FAILURE AND HOME HEALTH RN REPLACED BATTERIES BUT STILL WAS ABLE TO WORK. HOME HEALTH RN STARTED WITH GRAVITY. 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 - 60GM. PRIVIGEN SDV INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED; IMMUNODEFICIENCY, UNSPECIFIED; NONFAMILIAL HYPOGAMMAGLOBULINEMIA. DID PT MISS A DOSE OR HAVE AN INTERRUPTION TO THERAPY? - YES; 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
    1611870 PUMP CURLIN 6000CMS PUMP, INFUSION FRN MOOG / ZEVEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male PRIVIGEN SDV.