MAUDE Adverse Event Report: ARIZANT HEALTHCARE INCORPORATED / 3M COMPANY RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM; WARMER, THERMAL, INFUSION FLUID

Device Problems Grounding Malfunction (1271); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Description

The plastic piece that insulates the connection between the ranger clamp and the iv pole has fallen off of almost all our units.The lack of this insulated piece causes the ranger blood/fluid warming unit to cause the iv pole to be grounded.Fda safety report id# (b)(4).

• Brand Name: RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ARIZANT HEALTHCARE INCORPORATED / 3M COMPANY; eden prairie MN 55344
• MDR Report Key: 14592538
• MDR Text Key: 293462709
• Report Number: MW5110067
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• 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: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1