BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CURLIN 6000CMS

    MDR report key: 23368323 · Received October 23, 2025

    Report

    Report Number
    MW5177882
    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
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PT'S MOTHER REPORTED PT'S PUMP IS NO LONGER WORKING, THEY BELIEVE IT IS THE INTERNAL BATTERY. 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: ELAPRASE SDV - 24MG. ELAPRASE SDV INDICATION: MUCOPOLYSACCHARIDOSIS, TYPE II; ENCOUNTER FOR ADJUSTMENT AND MANAGEMENT OF VASCULAR ACCESS DEVICE. 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
    1611872 PUMP CURLIN 6000CMS PUMP, INFUSION FRN MOOG / ZEVEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male ELAPRASE SDV.