BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CURLIN 6000CMS

    MDR report key: 23680446 · Received December 1, 2025

    Report

    Report Number
    MW5179584
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Report Date
    November 24, 2025
    Manufacturer
    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) PT'S NURSE REPORTED PT IS NOT WORKING. PT IS SHOWING "ERROR" MESSAGE. 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 - 36GM. ELAPRASE SDV INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. 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. DIAGNOSIS FOR USE: MUCOPOLYSACCHARIDOSIS, TYPE II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054063 PUMP CURLIN 6000CMS PUMP, INFUSION FRN ZEVEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male ELAPRASE SDV.