BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 23465728 · Received November 4, 2025

    Report

    Report Number
    MW5178482
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Report Date
    October 31, 2025
    Manufacturer
    MOOG / ZEVEX, INC.
    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 THEIR PUMP STOPPED WORKING, THE SPRING HAS GIVEN OUT. 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: CUTAQUIG SDV - 36GM. CUTAQUIG SDV INDICATION: OTHER COMMON VARIABLE IMMUNODEFICIENCIES. 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? - UNKNOWN; IS DEVICE ASSOCIATED WITH EVENT AVAILABLE FOR RETURN? - UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2677539 PUMP FREEDOM 60 PUMP, INFUSION FRN MOOG / ZEVEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male CUTAQUIG SDV