MAUDE Adverse Event Report: KORU MEDICAL SYSTEMS FREEDOM60 SYRINGE INFUSION SYSTEM; FREEDOM60 INFUSION PUMP

Model Number	F10050
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Koru medical became aware of a report stating the syringe flew out during infusion and the black tab wouldn't rewind.No adverse events were reported to have occurred.Good faith efforts were sent to the initial reporter on (b)(6) 2023, (b)(6) 2023, (b)(6) 2023, and (b)(6) 2023 for additional information.Responses were received from the initial reporter on (b)(6) 2023 and (b)(6) 2023 stating the event occurred during set up of the pump where the syringe flew out of the pump after loading and the black tab would not reset or move back in order to reattempt syringe load after initial issue.No adverse events occurred.The pump serial number was provided.The patient was described as a new user who has been using the pump for approximately 2 months.Good faith effort was sent to the initial reporter on (b)(6) 2023 regarding pump return.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.
Additional Manufacturer Narrative
A capa was previously initiated by koru medical to investigate syringe ejection malfunctions.If additional information becomes available, a supplemental report will be filed with the new information.

• Brand Name: FREEDOM60 SYRINGE INFUSION SYSTEM
• Common Device Name: FREEDOM60 INFUSION PUMP
• Manufacturer (Section D): KORU MEDICAL SYSTEMS; 100 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): KORU MEDICAL SYSTEMS; 100 corporate drive; mahwah NJ 07430
• Manufacturer Contact: kayla kerschus ; 100 corporate drive; mahwah, NJ 07430 ; 8456105588
• MDR Report Key: 18241537
• Report Number: 1318360-2023-00017
• Device Sequence Number: 7059558
• Product Code: FRN
• UDI-Device Identifier: 00659443000001
• UDI-Public: 00659443000001
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K200176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: F10050
• Device Lot Number: S.85280
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 11/30/2023
• Date Device Manufactured: 09/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown