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	01/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Koru medical became aware of a report stating during setup the syringe was loaded into the pump and when turned on, the syringe shot out of the pump.Attempted another time and it happened again.No one was injured.Another pump was used without difficulty.A return material authorization was opened for return of the pump to koru medical for evaluation.The pump was received by koru medical on (b)(6) 2024 and evaluated.The evaluation confirmed the pump had a clear crack in the nose of the pump near where the luer disc would go and is most likely the cause of the failure.It seems to be consistent with the pump being dropped.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 ; 8454692042
• MDR Report Key: 18597455
• Report Number: 1318360-2024-00002
• Device Sequence Number: 12793047
• Product Code: FRN
• UDI-Device Identifier: 00659443000001
• UDI-Public: 00659443000001
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/29/2024

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.82970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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