BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CURLIN 6000CMS

    MDR report key: 24604452 · Received March 16, 2026

    Report

    Report Number
    MW5185229
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 6, 2026
    Manufacturer
    MOOG,INC./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

    PATIENT REPORTED THEY WERE JUST ABOUT TO START INFUSION AND WHEN TURNING ON PUMP IT IS BEEPING LOUDLY SAYING SYSTEM TIMEOUT. RPH ADVISED THAT IS AN INTERNAL ERROR AND PUMP WILL NEED TO BE SERVICED. PATIENT'S HOME HEALTH REGISTERED NURSE IS USING GRAVITY TUBING FOR TODAY'S INFUSION, BUT PATIENT WILL NEED NEW PUMP FOR TOMORROW'S INFUSION. 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- 100GM. PRIVIGEN SDV INDICATION: MYASTHENIA GRAVIS WITH (ACUTE) EXACERBATION. DID PATIENT 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
    663345 PUMP CURLIN 6000CMS PUMP, INFUSION FRN MOOG,INC./ZEVEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female PRIVIGEN SDV.