BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM60 SYRINGE INFUSION SYSTEM

    MDR report key: 16845455 · Received May 1, 2023

    Report

    Report Number
    1318360-2023-00005
    Event Type
    Malfunction
    Date Received
    May 1, 2023
    Date of Event
    July 25, 2022
    Report Date
    May 1, 2023
    Manufacturer
    KORU MEDICAL SYSTEMS
    Product Code
    FRN
    UDI-DI
    00659443000001
    PMA / PMN Number
    K200176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THIS EVENT OCCURRED ON JULY 25, 2022 AND REPORTED TO INNOMAR STRATEGIES INC. AND EMED ON JULY 27, 2022 , THIS COMPLAINT WAS NOT FORWARDED TO KORU UNTIL APRIL 5, 2023. A CAPA HAS BEEN INITIATED BY KORU TO INVESTIGATE SYRINGE EJECTION COMPLAINTS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    KORU MEDICAL BECAME AWARE OF REPORT FOR AN EVENT WHICH OCCURRED IN CANADA STATING "I CHANGED THE SYRINGE IT LOADED FINE THEN SHOT THE SYRINGE OUT WITH SUCH FORCE IT ALMOST RIPPED OUT MY NEEDLES. I TRIED TO RELOAD THE SYRINGE BACK BUT THE DIAL WOULD NOT PUSH THE BLACK BAR INSIDE BACK TO LOAD THE SYRINGE. MY HUSBAND AND I HAD TO TAKE TURNS PUSHING WITH SUCH FORCE OUR HANDS HURT AFTERWARDS. WE HAD TO MANUALLY PUSH IT IN HOPING IT WOULD GO IN IT TOOK ALMOST 2 HOURS TO DO IT. I DID NOT WANT TO WASTE MEDICINE AND DID NOT WANT TO HAVE TO DO ANOTHER INFUSION SO WE MANUALLY PUSHED IT. I HAVE HAD THIS PUMP FOR A FEW YEARS AND AM ALWAYS CAREFUL, I BELIEVE THE SPRING BROKE INSIDE THAT'S MY IDEA." FREEDOM 60 SYRINGE INFUSION PUMP MODEL-F10050/LOT 155/SERIAL (B)(6) WAS INVOLVED IN THE EVENT. THE PATIENT WAS ALSO USING BD 50ML SYRINGE LUER-LOK TIP LOT #1145490, NEEDLE SET LOT #2105023 (NON-KORU PRODUCT, MANUFACTURER UNKNOWN), AND EMED VERSARATE PLUS ADJUSTABLE FLOW RATE INFUSION SET REF#FP-0010026 LOT#2106022 TO INFUSE CUVITRU (16G/WEEK). IT WAS ALSO STATED THAT THE FREEDOM60 PUMP WAS NOT AVAILABLE FOR RETURN. A GOOD FAITH EFFORT WAS SENT TO THE INITIAL REPORTER ON 11-APR-2023 FOR ADDITIONAL INFORMATION. A RESPONSE WAS RECEIVED STATING NO FURTHER INFORMATION WAS AVAILABLE. AT THIS TIME, THE FREEDOM60 PUMP HAS NOT BEEN RETURNED TO KORU MEDICAL FOR EVALUATION. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702296 FREEDOM60 SYRINGE INFUSION SYSTEM FREEDOM60 INFUSION PUMP FRN KORU MEDICAL SYSTEMS F10050 155 00659443000001

    Patients

    Seq Age Sex Outcome Treatment
    1 Female