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

Model Number 24200

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Air Embolism (1697)

Event Date 12/16/2016

Event Type  Injury  

Event 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
• Type of Device: FLUID WARMING SET STD FLOW
• Manufacturer (Section D): 3M COMPANY; saint paul MN
• MDR Report Key: 6386796
• MDR Text Key: 69479739
• Report Number: MW5068316
• Device Sequence Number: 1
• Product Code: KZL
• UDI-Device Identifier: 30608223242002
• UDI-Public: 30608223242002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 24200
• Device Catalogue Number: 24200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 77