BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 12908475 · Received November 30, 2021

    Report

    Report Number
    MW5105677
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Report Date
    November 18, 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: CHRONIC INFLAMMATORY DEMYELINATING POLYNEURITIS: INBOUND CALL FROM PATIENT STATING THAT HER SOMETHING ON HER PUMP WAS BROKEN (NO FURTHER DETAILS AT THIS TIME). UNKNOWN IF PT MISSED A DOSE; NO ADVERSE EVENT REPORTED- UNKNOWN IF AVAILABLE FOR RETURN; UNKNOWN LOT/EXPIRATION. UNKNOWN IF MD AWARE. NO FURTHER INFORMATION KNOWN. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801170 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Female