BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 10200256 · Received June 25, 2020

    Report

    Report Number
    MW5095233
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Report Date
    June 17, 2020
    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

    INDICATION - COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED FREEDOM PUMP BROKE AT THE END OF THE INFUSION. NO REPORTED ADVERSE EVENT. NO REPORTED MISSED DOSE. SOLICITED CALL - NO FURTHER INFO PROVIDED. UNK IF DEVICE IS STILL ON HAND IN CASE A RETURN IS REQUESTED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657638 PUMP FREEDOM 60 INFUSION PUMP FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1