BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM 60 PUMP

    MDR report key: 20170119 · Received September 6, 2024

    Report

    Report Number
    MW5159312
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 28, 2024
    Manufacturer
    KORU MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    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 HER DOSE TODAY WAS INFUSED FASTER OVER 30 MINUTES INSTEAD OF USUAL INFUSION TIME DOSE TO 60- 70 MINUTES DUE TO MALFUNCTION. PT. REPORTS HEADACHE AND NAUSEA. MALFUNCTIONED FREEDOM 60PUMP SERIAL NUMBER (B)(6). NO ADDITIONAL DETAILS OF MALFUNCTION WERE REPORTED. MAINTENANCE DUE DATE IS UNKNOWN. NO INTERRUPTION TO INFUSION OR MISSED DOSE REPORTED; NOT AVAILABLE FOR RETURN; UNKNOWN IF MD AWARE. NO FURTHER INFO PROVIDED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297591 FREEDOM 60 PUMP PUMP, INFUSION FRN KORU MEDICAL SYSTEMS, INC. F10050

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female XEMBIFY SDV