BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 17436798 · Received July 31, 2023

    Report

    Report Number
    MW5120434
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Report Date
    May 26, 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. PT REPORTED THAT HER PUMP STOPPED. NO FURTHER INFORMATION IS KNOWN. UNKNOWN IF MD IS AWARE. NO MISSED DOSES REPORTED. UNKNOWN IF THE PATIENT EXPERIENCED AN ADVERSE EVENT AS A RESULT OF THE DEFECTIVE PRODUCT. UNKNOWN IF THE PT HAS THE DEFECTIVE PRODUCT ON HAND FOR POSSIBLE RETURN TO THE MANUFACTURER. NO FURTHER INFORMATION IS KNOWN. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772466 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female