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	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information was provided.No staff or patient injury occurred.The customer reported two lot #'s, hw8255 and hw8284 , were associated with this reported incident.Lot # hw8284 was manufactured on dec 11, 2018 with an expiration date of dec 11, 2021.Reporter's occupation was not provided.The sample has not been received by 3m st.Paul, mn 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 alleged leak in fluid warming bag from lot hw8284 is potentially a bubble trap leak.The sample is needed to fully determine to root cause.The alleged leak in fluid warming bag from lot hw8255 appears to potentially be a heat exchanger leak.This lot was produced prior to the implementation of the improvement project.Rf tooling frame die flatness improvement project implementation was completed on (b)(6) 2019.3m will continue to monitor.
Event or Problem Description
A hospital employee alleged two 3m¿ ranger¿ high flow disposable sets (model 24365) leaked saline fluid during priming on (b)(6) 2019.The sets were reportedly primed to gravity.One set reportedly leaked saline from the bubble trap.The second set reportedly leaked saline near the tubing insertion into the cassette.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.One sample from lot hx8255 was received and evaluated.A leak was verified at the inlet port of the heat exchanger.Product lot number was produced prior to implementation of corrective action.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: 9252114
• Report Number: 2110898-2019-00125
• Device Sequence Number: 11270207
• 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: 10/29/2019
• 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