BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 19998698 · Received August 15, 2024

    Report

    Report Number
    MW5158525
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    August 12, 2024
    Report Date
    August 12, 2024
    Manufacturer
    KORU MEDICAL 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

    PATIENT REPORTS INFUSED XEMBIFY TODAY WITH F900 TUBING BUT INFUSION WAS 2 HOURS AND 15 MINUTES INSTEAD OF ESTIMATED 3 HOURS 20 MINUTES. PATIENT IS CONCERNED IT IS A PUMP ISSUE SINCE EACH 50ML SYRINGE SHE USED FOR HER TOTAL 150ML DOSE WAS CONSISTENTLY 45 MINUTES EACH. NO ADVERSE EVENT REPORTED DUE TO PC. NO INTERRUPTION TO THERAPY OR MISSED DOSE DUE TO PC. DEFECTIVE DEVICE IS AVAILABLE FOR RETURN & IS BEING REPLACED. THE SUSPECT DEVICE SERIAL NUMBER WAS NOT PROVIDED BY THE PATIENT THE FOLLOWING DEVICE SERIAL NUMBER IS CURRENTLY CHECKED OUT BY THE PATIENT FOR USE: (B)(6). NO ADDITIONAL INFORMATION WAS PROVIDED. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619995 PUMP FREEDOM 60 PUMP, INFUSION FRN KORU MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female DIPHENHYDRAMINE (ALLERGY).| EPINEPHRINE AUTO-INJ.| XEMBIFY SDV.