MAUDE Adverse Event Report: 3M RANGER BLOOD/FLUID WARNING SYSTEM WITH SMARTHEAT TECHNOLOGY HIGH FLOW DISPOSABLE; RANGER HIGH FLOW INFUSION TUBING

Model Number 24355

Device Problems Collapse (1099); Disconnection (1171); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Device Contamination with Body Fluid (2317); Improper Flow or Infusion (2954)

Patient Problem Exposure to Body Fluids (1745)

Event Type  Injury  

Event Description

Our emergency department and icu teams have experienced recurrent product malfunction while using the 3m ranger pressure infuser (model 145) and blood warmer (model 245) with our trauma population.In 2017, 7 events have been reported and there have been additional general concerns shared with our clinical education and engineering teams.When attempting to infuse using the equipment's pressure infusion system with the appropriate high flow disposable set tubing (product number 24355), the tubing connections above and below the warming cassette become disconnected or loosen, resulting in either a leak or forceful spray of blood product onto clinicians, patients, and other needed equipment.This has happened in cases after clear confirmation that line connections were checked, tightened, and primed per manufacturer guidelines.The tubing spike, having been double checked for proper connection, also becomes dislodged resulting in forceful blood spray.Per clinicians, the infusion rate for this device is often between 50 and 100 ml/min using a minimum of an 18 gauge piv.Marketing materials represent infusion rates of up to 500 ml/min.While the product is infusing, clinicians have observed the blood product bag collapsing in on itself despite the pressure infuser bladder being fully inflated.This impedes full transfusion and reduces equal pressure, resulting in observed decreased infusion rate.Regarding sprayed blood product, we are concerned about the potential infection risk to our employees, and the waste of blood product in a trauma environment.Regarding infusion rate and stopped infusion due to sprayed product, we are concerned this might impact the efficiency of resuscitating our patients.

• Brand Name: RANGER BLOOD/FLUID WARNING SYSTEM WITH SMARTHEAT TECHNOLOGY HIGH FLOW DISPOSABLE
• Type of Device: RANGER HIGH FLOW INFUSION TUBING
• Manufacturer (Section D): 3M; st. paul MN 55144
• MDR Report Key: 6489420
• MDR Text Key: 72876158
• Report Number: MW5069065
• Device Sequence Number: 1
• Product Code: FKB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24355
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention