MAUDE Adverse Event Report: VYAIRE MEDICAL ENFLOW CONTROLLER UNIT; WARMER, THERMAL, INFUSION FLUID

Model Number	ENFLOW CONTROLLER UNIT
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be available for evaluation as it is currently being used in a clinical study and has been determined to be unrelated to the adverse event.However, the device history record was being reviewed to detect in any issue.At this time, the root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The clinical research associate, medical affairs consumables of vyaire medical reported that there was an adverse event reported during the enflow pmcf clinical study.At the end of the surgery, it was observed that after changing the fluid to sodium chloride, the patients vein had ruptured.The vein damage was assessed to be caused by poor cannula placement or the patient's vein could not withstand the pressure.

• Brand Name: ENFLOW CONTROLLER UNIT
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.; 15/f., block b, veristrong; industrial, 36 au pui wan st.; fotan, ; HK
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, CA 92618
• MDR Report Key: 14795270
• Report Number: 3008959444-2022-00011
• Device Sequence Number: 5050517
• Product Code: LGZ
• UDI-Device Identifier: 10190752125803
• UDI-Public: (01)10190752125803
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ENFLOW CONTROLLER UNIT
• Device Catalogue Number: 980121EU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability
• Patient Sex: Unknown