MAUDE Adverse Event Report: 410 MEDICAL LIFEFLOW

Model Number	FG5001
Health Effect - Clinical Code	Embolism (1829)
Date of Event	04/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Chief medical officer and engineering personnel inspection and testing of the lifeflow device used on the patient indicated the device was functioning correctly and in specification.Patient was sent for hyperbaric therapy and subsequently released without any reported residual health issues.A detailed investigation was conducted by appropriate hospital personnel at (b)(6) and 410 medical.The cause of the presumed air embolism is unknown.According to (b)(6) staff, the nurses using the lifeflow device had recently been trained, used it according to the manufacturer instructions, noted no problems with the infusion and felt that fluid administered via the lifeflow resulted in improvement in the patient's condition.At least 3 other fluid infusion methods were used on this patient, each of which has known risk of causing air embolism.This submission was delayed due to troubles setting up a webtrader account please see esg help desk ticket (b)(4) for details.
Event or Problem Description
Patient noted to have moderate amount of air in right atrium, right ventricle, internal mammary region, as well as a mild amount of air along anterior right chest and neck with cta.Lifeflow manual rapid infuser used to infuse fluids along with pressure bag and tubing for rapid infusion of 1 liter of saline, iv pump for infusion of norepinephrine and a ct contrast infuser.

• Brand Name: LIFEFLOW
• Common Device Name: LIFEFLOW
• Manufacturer (Section D): 410 MEDICAL; 201 west main street; suite 207; durham NC 27701
• MDR Report Key: 6750397
• Report Number: 3012969104-2017-00001
• Device Sequence Number: 16454538
• Product Code: FPA
• UDI-Device Identifier: B355FG50011
• UDI-Public: B355FG50011
• Combination Product (Y/N): N
• PMA/510(K) Number: K153731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/05/2017

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: Nurse
• Device Expiration Date: 01/11/2019
• Device Model Number: FG5001
• Device Catalogue Number: FG5001
• Device Lot Number: 6035
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 07/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 22 YR
• Patient Weight: 79