MAUDE Adverse Event Report: 3M COMPANY 3M RANGER; FLUID WARMING SET STD FLOW

Model Number	24200
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	12/16/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
During surgery, the bubble trap did not effectively expunge air, thereby causing an air embolism.A 24200 ranger fluid warmined set std flow 10/cs - 3mid - (b)(4).

• Brand Name: 3M RANGER
• Common Device Name: FLUID WARMING SET STD FLOW
• Manufacturer (Section D): 3M COMPANY; saint paul MN
• MDR Report Key: 6386796
• Report Number: MW5068316
• Device Sequence Number: 512692
• Product Code: KZL
• UDI-Device Identifier: 30608223242002
• UDI-Public: 30608223242002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2017

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?: Yes
• Operator of Device: No Information
• Device Model Number: 24200
• Device Catalogue Number: 24200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2017
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 77