BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 10148346 · Received June 11, 2020

    Report

    Report Number
    MW5094970
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    June 7, 2020
    Report Date
    June 8, 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 INDICATING THAT HER FREEDOM PUMP HAS BROKEN; SHE STATES THAT THE BACK HANDLE WILL NOT GO BACK ANY FURTHER; SHE DREW UP THE MEDICATION AT 4 PM ON SUNDAY (B)(6) 2020, BUT DIDN'T NOTIFY PHARMACY UNTIL (B)(6) 2020 AND MANUFACTURE ADVISED THAT THEY CANNOT RECOMMEND USING THE MEDICATION STORED IN A SYRINGE FOR THAT LENGTH OF TIME. THUS PATIENT MISSED DOSE AND WILL NEED MAKE-UP DOSE OF MEDICATION FOR REPLACEMENT, AS WELL AS A NEW PUMP FOR REPLACEMENT; NO ADVERSE EVENTS REPORTED AS A RESULT OF MISSED DOSE; NOT SPECIFIED IF PATIENT HAS DEFECTIVE DEVICE ON HAND FOR RETURN; NO LOT NUMBER OR EXPIRATION DATE PROVIDED; NO FURTHER INFORMATION. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609933 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS F10050

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR