BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CURLIN 6000CMS

    MDR report key: 23368172 · Received October 23, 2025

    Report

    Report Number
    MW5177878
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    September 15, 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

    PT'S HOME HEALTH RN REPORTED PT'S PUMP KEEPS BEEPING WITH "AIR IN LINE", WHICH STARTED ABOUT 30 MINUTES INTO INFUSION. HOME HEALTH RN RESTARTED PUMP DURING INFUSION AND IT FINISHED RUNNING BUT HOME HEALTH RN STILL HAS ABOUT 100ML REMAINING. RPH PROVIDED REPROGRAMMING CODE TO HOME HEALTH RUN TO REPROGRAM REMAINDER OF INFUSION TO BE RUN OVER 2 HOURS. HOME HEALTH RN ALSO HAS SUPPLIES ON HAND TO RUN VIA GRAVITY IF NEEDED. PT WILL NEED NEW PUMP. 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 - 25GM. GAMUNEX-C SDV INDICATION: ANTIBODY DEFICIENCY WITH NEAR-NORMAL IMMUNOGLOBULINS OR WITH HYPERIMMUNOGLOBULINEMIA. 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
    1611868 PUMP CURLIN 6000CMS PUMP, INFUSION FRN MOOG / ZEVEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female GAMUNEX-C 10% SDV (20GM/200ML).| GAMUNEX-C 10% SDV (5GM/50ML).