BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM60 PUMP

    MDR report key: 12658635 · Received October 18, 2021

    Report

    Report Number
    MW5104710
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Report Date
    June 1, 2021
    Manufacturer
    REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL FROM PATIENT'S DAUGHTER, WHO REPORTED THAT THE PUMP IS NOT WORKING AND THE SPRING IS WORN OUT UNKNOWN IF PRODUCT FAULT OCCURRED WHILE IN USE WITH THE PATIENT. UNKNOWN IF PATIENT HAD A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO. UNKNOWN IF PATIENT HAD ANY MISSED DOSES OR SIDE EFFECTS AS A RESULT. LOT NUMBER/SERIAL NUMBER AND EXPIRATION DATE ARE UNKNOWN. PUMP IS STILL ON HAND FOR RETURN AND RETURN BOX IS BEING SENT TO PATIENT. PATIENT HAS HAD PUMP FOR OVER 4YEARS AND NEW PUMP WAS NEEDED. NO FURTHER INFORMATION. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550104 FREEDOM60 PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS F10050

    Patients

    Seq Age Sex Outcome Treatment
    1