BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM60 PUMP

    MDR report key: 20291047 · Received September 20, 2024

    Report

    Report Number
    MW5159957
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Report Date
    September 19, 2024
    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 (PATIENT) REPORTS THAT THE NEW FREEDOM60 PUMP (SERIAL NUMBER AND MAINTENANCE DUE DATE NOT SPECIFIED) JUST RECEIVED IS BROKEN. PT STATED THAT WHEN SHE USES THE WIND-UP KNOB TO MOVE THE BLACK TAB TO THE BACKEND OF ITS TRACK THE SPRING UNDERNEATH/INSIDE THE PUMP BROKE AND FLEW OUT. PT STATED BLACK TAB NOW UNABLE TO MOVE, AND THE PUMP IS UNUSABLE. PATIENT STATED SHE CAN ALSO HEAR AUDIBLE RATTLING INSIDE THE PUMP FROM THE BROKEN SPRING, WHICH PHARMACIST ALSO HEARD ON WHEN SPEAKING TO THE PT. PT DID NOT SPECIFY WHEN THIS OCCURRED. PT STATED NO MISSED DOSE OF MEDICATION, SHIES CURRENTLY COMPLETING AN INFUSION VIA A SLOW MANUAL SUBCUTANEOUS PUSH INSTEAD OF THE PUMP. PT STATED NO ADVERSE EVENT DUE TO PUMP ISSUE OR NOT BEING ABLE TO USE PUMP, PT SELF-DISPOSING OF PUMP AND IT WILL NOT BE RETURNED TO PHARMACY. PHARMACY REPLACING PUMP ASSOCIATED WITH EVENT. NO FURTHER INFORMATION. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243527 FREEDOM60 PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female HIZENTRA 20% PFS (10GM TOTAL).