BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 14195419 · Received April 22, 2022

    Report

    Report Number
    MW5109333
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Report Date
    March 10, 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
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INDICATION - ILLNESS, UNSPECIFIED AND COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. PATIENT STATES THAT THE PLASTIC COVERING ON THE PUMP IS COMING OFF, AND HE HAS TO POP BACK IN PLACE. NO ADVERSE EFFECTS REPORTED FROM DEFECTIVE PUMP. PUMP BEING REPLACED. UNKNOWN IF OLD PUMP AVAILABLE FOR RETURN. SPONTANEOUS CALL - NO FURTHER INFO PROVIDED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479273 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Male