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	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Koru medical became aware of mw5149840 received through the fda medwatch program stating "indication: selective deficiency of immunoglobulin [lgg] subclasses.Unsolicited communication from the patient.Patient reported that her freedom60 pump is not working.When the patient tried to start her infusion the 50/ml syringe which contained hizentra jumped out of pump.When the patient tried to put the syringe back into the pump, the turning knob was not working.Patient had been trying to trouble shoot with the pump for about 3-4 hours.Patient reported hizentra dose was missed/wasted due to pump failure.Pt did not report any adverse events due to defective device.Defective device is available for return to the manufacturer.Product lot number is unknown.No additional information available.Reported to (b)(6) by pt/caregiver." a good faith effort was sent to the initial reporter on 29-jan-2024 for additional information.A response was received providing patient information and the serial number of the pump involved.The pump listed in this report was received by koru medical on 17-jan-2024.Inspection findings include pump not winding, black tab will not wind back.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: 18763859
• Report Number: 1318360-2024-00003
• Device Sequence Number: 7795037
• Product Code: FRN
• UDI-Device Identifier: 00659443000001
• UDI-Public: 00659443000001
• Combination Product (Y/N): N
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2024

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.85489
• 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: 01/25/2024
• Initial Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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 Age: 76 YR
• Patient Sex: Female