BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 17436814 · Received July 31, 2023

    Report

    Report Number
    MW5120437
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Report Date
    June 6, 2023
    Manufacturer
    REPRO-MED SYSTEMS, 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

    SPONTANEOUS. PATIENT REPORTED HER INFUSION LASTS ABOUT 1 HOUR 20 MINUTES. THIS TIME, IT LASTED OVER 2 HOURS. SHE MADE SURE SHE INSERTED NEEDLE WELL; NEEDLE SET AND TUBING IS APPROPRIATE. PATIENT WAS ABLE TO FINISH INFUSION. ADVISED TO USE NEW PUMP NEXT TIME AND IF ANY ISSUES, CALL US FOR ASSISTANCE. DATE OF MALFUNCTION IS UNKNOWN. NO MISSED DOSE OR ADVERSE EVENTS REPORTED. PUMP ON HAND FOR RETURN TO MANUFACTURER. NO FURTHER INFORMATION. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773297 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female