MAUDE Adverse Event Report: 3M HEALTH CARE 3M RANGER(TM) HIGH FLOW BLOOD/FLUID DISPOSABLE SET; HIGH 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	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information was provided.Reporter's occupation was not provided.The sample was not returned for evaluation.3m was unable to verify the leak, identify exact location and root cause without the sample.Based on the information provided leakage appears to have occurred at the port area of the heat exchanger.3m will continue to monitor.
Event or Problem Description
A hospital employee alleged a 3m¿ ranger¿ high flow disposable set (model 24365) leaked fluid at the side, near the filter.No patient/staff injury was alleged.No additional information was provided.
Additional Manufacturer Narrative
Method, results and conclusion codes updated to reflect analysis findings.Three sets from lot hw8284 were received for analysis.One set had a leak at the perimeter of the heat exchanger.One set had a leak at the inlet and outlet port of the heat exchanger.One set had a leak in the bubble trap.Product lot hw8284 was produced prior to implementation of corrective action for the heat exchanger and bubble trap leak.3m will continue to monitor.End of report.

• Brand Name: 3M RANGER(TM) HIGH FLOW BLOOD/FLUID DISPOSABLE SET
• Common Device Name: HIGH FLOW DISPOSABLE TUBING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 9519822
• Report Number: 2110898-2019-00153
• Device Sequence Number: 595474
• Product Code: BSB
• UDI-Device Identifier: 00707387781460
• UDI-Public: 00707387781460
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K973741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 12/11/2021
• Device Model Number: N/A
• Device Catalogue Number: 24365
• Device Lot Number: HW8284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1