BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 17436822 · Received July 31, 2023

    Report

    Report Number
    MW5120438
    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

    PT REPORTED SHE TRAVELED WITH HER FREEDOM PUMP AND AFTERWARDS IT HAS NOT BEEN WORKING WELL. THERE IS A PROBLEM WITH THE SPRING AND SHUTTING OFF AND ON. SHE WAS STILL ABLE TO INFUSE WITH IT. PHARMACIST SENDING A REPLACEMENT PUMP. NO MISSED DOSE OR ADVERSE EVENT REPORTED. PUMP AVAILABLE FOR RETURN TO MANUFACTURER. NO FURTHER INFORMATION. INDICATIONS: MYASTHENIA GRAVIS; MYASTHENIA GRAVIS WITHOUT [ACUTE] EXACERBATION. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773298 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female