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	11/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information was provided.Reporter's occupation was not provided.The sample has not been received by 3m (b)(6) for evaluation.3m was unable to verify the leak location and the identify the root cause without the sample.Analysis is pending on returned sample to verify leakage location.3m will continue to monitor.
Event or Problem Description
A hospital employee alleged a 3m¿ ranger¿ high flow disposable set (model 24365) leaked fluid around the side of the auto-venting bubble trap.The employee alleged the cassette burst while a patient (age/gender not specified) was being resuscitated.No patient injury was alleged.No additional information was provided.

• 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: 9473833
• Report Number: 2110898-2019-00148
• Device Sequence Number: 14150641
• 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
• Report Date (Section B): 12/16/2019

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: 12/11/2021
• Device Model Number: N/A
• Device Catalogue Number: 24365
• Device Lot Number: HW8284
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1