BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP FREEDOM 60

    MDR report key: 10361479 · Received August 3, 2020

    Report

    Report Number
    MW5095850
    Event Type
    Injury
    Date Received
    August 3, 2020
    Report Date
    July 29, 2020
    Manufacturer
    REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL-PATIENT REPORTED SYRINGE IS COMING OUT OF THE PUMP MULTIPLE TIMES DICTATING THEA PUMP WING KNOB IS NOT DIALING CORRECTLY. ADVISED OF MANUAL PUSH - PATIENT INFORMED THAT SHE HAD BEEN HOSPITALIZED WITH COVID TWICE AND IS VERY WEAK AND THEREFORE HAS NOT STRENGTH TO PUSH (UNSPECIFIED DATES/LENGTH OF STAY). NO FURTHER INFORMATION AVAILABLE INDICATION: OTHER IMMUNODEFICIENCIES WITH PREDOMINANTLY ANTIBODY DEFECTS, ABNORMALITY OF GLOBULIN. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER. DATES OF USE: (B)(6) 2020 TO CURRENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824593 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1