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	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information was provided.No staff or patient injury occurred.Reporter's occupation was not provided.The sample was not returned for evaluation.3m was unable to verify the leak location and the identify the root cause without the sample.Based on the problem reported, the probable cause of the leak is over-pressurization with the hand pump.The product ifu states the following: caution · do not exceed 300mmhg pressure.3m will continue to monitor.
Event or Problem Description
A hospital employee alleged a 3m¿ ranger¿ high flow disposable set (model 24365) leaked rbc fluid near the bubble trap during administration on (b)(6) 2019.A peripheral iv was used for the infusion.A baxter y-type blood/solution set with a large standard blood filter and pressure pump was used to apply manual/hand pressure.The anesthesia team reportedly became contaminated.The procedure was reportedly delayed due to the removal and replacement of the blood warming and transfusion components.No patient or staff injury was alleged.
Additional Manufacturer Narrative
Results and conclusion codes updated to reflect analysis findings.Additional code added to method section.The returned sample was evaluated.A leak was verified at the inlet port of the heat exchanger.Product lot, hw8284, was produced prior to implementation of corrective action.

• 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: 9244372
• Report Number: 2110898-2019-00124
• Device Sequence Number: 13565079
• 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): 01/02/2020

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: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 24365
• Device Lot Number: HW8255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1