BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 17436806 · Received July 31, 2023

    Report

    Report Number
    MW5120436
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Report Date
    June 28, 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 THAT HER FREEDOM PUMP BROKE DURING INFUSION. SHE REPORTED THAT IT STOPPED WORKING IN THE MIDDLE OF HER INFUSION. THE PATIENT WAS ALMOST DONE WITH HER INFUSION. SHE WAS ABLE TO COMPLETE HER INFUSION WHILE HOLDING THE PUMP WITH RUBBER BANDS. NO FURTHER INFORMATION REPORTED. UNKNOWN DATE OF MALFUNCTION. UNKNOWN IF THE PATIENT HAD THE MEDICATION ON HAND FOR RETURN. UNKNOWN IF THE PATIENT EXPERIENCED AN ADVERSE EVENT. UNKNOWN IF THE PATIENT MISSED A DOSE. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773296 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female