BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM 60 - PUMP

    MDR report key: 9983104 · Received April 20, 2020

    Report

    Report Number
    MW5094210
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Report Date
    April 6, 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

    SPONTANEOUS INBOUND CALL FROM PATIENT STATING THAT THE PUMP MALFUNCTIONED AND WAS NOT ABLE TO LOAD SYRINGE IN PUMP. SPRING WOULD NOT LOCK IN PLACE. PHARMACIST ADVISED WILL NEED TO REPLACE AND PATIENT WILL NEED A MAKEUP DOSE BECAUSE PATIENT WAS NOT ABLE TO INFUSE. NO ADVERSE EFFECTS NOTED FROM MISSED DOSE. NO OTHER INFORMATION KNOWN. 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
    440497 FREEDOM 60 - PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1