BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN 6000

    MDR report key: 20577755 · Received October 30, 2024

    Report

    Report Number
    MW5161931
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 16, 2024
    Report Date
    October 16, 2024
    Manufacturer
    MOOD / ZEVEX, INC.
    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

    HOME INFUSION NURSE (B)(6), RN REPORTED AN ERROR MASSAGE WHEN USING PUMP ON (B)(6)2024. PUMP ERROR 30.1. RESTARTING AND CHANGING BATTERIES DID NOT HELP. NURSE WILL GIVE GRAVITY INFUSION THIS ROUND. NO OTHER SPECIFICS REGARDING DEFECTIVE DEVICE PROVIDED. NO MISSED DOSES REPORTED. NO ADVERSE EVENTS REPORTED, UNKNOWN IF DEVICE AVAILABLE FOR RETURN. PUMP SERIAL NUMBER IS (B)(6). NO ADDITIONAL INFORMATION AVAILABLE. REPORTED TO CVS/CAREMARK BY HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065631 CURLIN 6000 PUMP, INFUSION FRN MOOD / ZEVEX, INC. 6000

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female BACTERIOSTATIC WATER MDV.| METHYLPRED SOD SUCC SDV.| NORMAL SALINE FLUSH (5ML).| OCREVUS SDV.| SODIUM CHLOR (500ML/BAG).