BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CURLIN 6000CMS

    MDR report key: 24931803 · Received April 20, 2026

    Report

    Report Number
    MW5187018
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    March 3, 2026
    Report Date
    April 16, 2026
    Manufacturer
    ZEVEX INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) HOME HEALTH REGISTERED NURSE REPORTED PATIENT'S PUMP IS TURNED ON AND IT GIVES A CONTINUOUS ALARM, THEN SAYS SYSTEM TIMEOUT AND IT WILL NOT ALLOW THE REGISTERED NURSE TO DO ANYTHING. HOME HEALTH REGISTERED NURSE WHEN THROUGH TROUBLESHOOTING, CHANGED BATTERIES AND RESTARTED AND DISCONNECTED TUBING, BUT IS STILL BEEPING. INTERNAL BATTERY SEEMS DEAD. NO MEDICATION WAS PULLED AND PATIENT DID NOT EXPERIENCE ANY SYMPTOMS. HOME HEALTH REGISTERED NURSE REPORTED DOSE WILL NOT BE MISSED BECAUSE REGISTERED NURSE WILL INFUSE ON (B)(6) 2026. PUMP SERIAL NUMBER PROVIDED: (B)(6), EXPIRATION PROVIDED ON 12/01/2026. NO FURTHER INFORMATION, DETAILS OR DATES AVAILABLE. PRODUCT LOT AND EXPIRATION UNKNOWN. UNKNOWN IF MD IS AWARE. DOSE/AMOUNT: GAMUNEX-C 10% SDV (40 GM/400 ML) - 120GM. GAMUNEX-C 10% SDV(40 GM/400 ML) INDICATION: CHRONIC INFLAMMATORY DEMYELINATING POLYNEURITIS. 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
    992646 PUMP CURLIN 6000CMS PUMP, INFUSION FRN ZEVEX INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male GAMUNEX-C 10% SDV (40 GM/400 ML)| PREDNISONE