MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RANGER¿ BLOOD/FLUID WARMING STANDARD FLOW; BAIR HUGGER BLOOD/FLUID WARMER

Catalog Number 24200

Device Problem Use of Device Problem (1670)

Patient Problem Air Embolism (1697)

Event Date 12/20/2023

Event Type  Injury  

Event Description

A user facility reported a hypothermic female patient in her late 40's was transported to the emergency room.The patient was given a bolus and 3m¿ ranger¿ blood/fluid warming standard flow set, 24200 was initiated.It was not identified if the bolus was given before initiating the ranger or if it was given through the ranger set.The patient was then transferred to computed tomography (ct) with the ranger attached to an intravenous (iv) line pole where a large amount of air in the vascular system was found.The patient was transferred to a hospital for hyperbaric treatment and intensive care.The patient has been discharged from the hospital.

Manufacturer Narrative

H10: the device has been discarded; therefore, not returned to 3m for analysis.The hospital later recognized there was a user error.The bubble trap was not filled with fluid during priming and the bubble trap was not placed in the holder.Education needs were recognized and are currently in process.Based on the problem description provided, a likely cause is improper use of the ranger fluid warming system resulting in air embolism.Additional information is required to identify the root cause of air embolism.Potential causes include incorrect positioning of the heating unit, pressurization of a pediatric set, improper priming of the disposable set, or inadvertent administration of air into the system.Instructions for use include to reduce the risks associated with air embolism and incorrect routing of fluids include never infuse fluids if air bubbles are present in the fluid line and ensure all leur connections are tightened.Do not mount the ranger blood fluid warming system higher than patient level during infusion, as air embolism may result.High flow disposable set is the recommended model to use in the event of a trauma situation depending on the volume of replacement fluid required for patient.3m will continue to monitor.

• Brand Name: 3M¿ RANGER¿ BLOOD/FLUID WARMING STANDARD FLOW
• Type of Device: BAIR HUGGER BLOOD/FLUID WARMER
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): NYPRO PRECISION ASSEMBLIES; sor juana ines de la cruz; cd. industrial; tijuana, tijuana baja california 22444 ; MX 22444
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN
• MDR Report Key: 18530863
• MDR Text Key: 333085657
• Report Number: 2110898-2024-00003
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 50608223242006
• UDI-Public: 50608223242006
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K973741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 24200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female