BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN PUMP 6000 CMS

    MDR report key: 19606488 · Received June 24, 2024

    Report

    Report Number
    MW5156551
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    June 21, 2024
    Report Date
    June 21, 2024
    Manufacturer
    MOOG COSTA RICA, SRL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GAMUNEX STRENGTH: GAMUNEX-C 10% SDV (2.5GM/25ML) AND GAMUNEX-C 10% SDV (10GM/100ML). GAMUNEX FREQUENCY: INTRAVENOUSLY DAILY FOR 2 DAYS EVERY 2 WEEKS. UNSOLICITED: PATIENT REPORTED CURLIN PUMP (SERIAL NUMBER: NOT PROVIDED; MAINTENANCE DUE: NOT PROVIDED) STATING ERROR SYSTEM TIMEOUT, EMPTY LITHIUM BATTERY. ADVISED PATIENT PHARMACY WILL REPLACE THE PUMP AS THE INTERNAL BATTERY HAS FAILED, NOT RELATED TO THE REPLACEABLE C BATTERIES. PATIENT CURRENTLY ON DAY 1 OF 2 INFUSION. PATIENT CONFIRMED HOME HEALTH NURSE HAS BACK UP GRAVITY SUPPLIES ON HAND TO COMPLETE INFUSION TODAY. NO DOSE MISSED DUE TO FAULTY PUMP AT THIS TIME. NO ADVERSE EFFECTS OR EVENTS REPORTED DUE TO FAULTY PUMP AT THIS TIME. ISSUE WAS NOTICED PRIOR TO INFUSION STARTING. FAULTY PUMP IN PATIENT¿S POSSESSION AND RETURN BOX BEING SENT FOR PATIENT TO RETURN TO PHARMACY. NO FURTHER INFO. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626068 CURLIN PUMP 6000 CMS PUMP, INFUSION FRN MOOG COSTA RICA, SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female DEXAMETHASONE.| GAMUNEX-C.