MAUDE Adverse Event Report: 3M HEALTH CARE 3M RANGER¿ BLOOD/FLUID WARMING SYSTEM STANDARD FLOW; STANDARD FLOW DISPOSABLE TUBING

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product sample was discarded by the customer; therefore, analysis of the product could not be conducted.Without a sample or product photo, root cause of reported issue and exact location of the reported leak was unable to be determined.Based on the information provided, issue appears to be a heat exchanger leak.There currently have been no change in complaint levels for hex leaks.3m will continue to monitor.End of report.
Event or Problem Description
A hospital anesthesia technician reported a (b)(6) male patient, weighing 20kg, had liver transplant surgery on (b)(6) 2019.The patient was being administered rbc fluid through a 3m¿ ranger¿ standard flow disposable set (model 24200) warmed by a 3m¿ ranger¿ warming unit (model not specified).Prior to administration, the fluid warming cassette was loaded into the warming unit.The warming unit was turned off at this time.The patient was administered rbc fluid for approximately 2 to 2 ½ hours.No pressure device or pump was used.No manual pressure was applied to the fluid bags.The employee alleged, approximately 2 to 2 ½ hours after the start of administration, the anesthesiologist discovered blood was leaking from the ranger ¿ unit.The anesthesiologist took action to prevent any bodily harm to the patient.The employee reported the warming unit was unable to be evaluated at the hospital due to blood contamination.

• Brand Name: 3M RANGER¿ BLOOD/FLUID WARMING SYSTEM STANDARD FLOW
• Common Device Name: STANDARD FLOW DISPOSABLE TUBING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8564910
• Report Number: 2110898-2019-00059
• Device Sequence Number: 2232576
• Product Code: DWJ
• UDI-Device Identifier: 00707387781392
• UDI-Public: 00707387781392
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K973741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/18/2021
• Device Model Number: N/A
• Device Catalogue Number: 24200
• Device Lot Number: B8247
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 20