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	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information was provided.The product was not returned for evaluation.A video reflecting the leakage location was provided.The probable cause of the leak is over-pressurization of the unit due to non-controlled hand pressure application.This, however, can not be confirmed without a sample.3m will continue to monitor.
Event or Problem Description
An anesthesia assistant reported a male patient in his 70's was resuscitated in the operating room on (b)(6) 2019.The patient was being administered rbc fluid via a 3m¿ ranger¿ high flow disposable set (model 24365) warmed by a 3m¿ ranger¿ warming unit (model 24500).A large gauge needle for the cordis line was used for infusion.Manual hand pressure was applied.The employee alleged a fluid leaked occurred from the side of the auto venting bubble trap during infusion.The patient's care was reportedly delayed in order to re-establish the blood infusion via an alternate method, a fms belmont machine.The anesthesiologist was reportedly exposed to blood.No blood cultures were done.No staff injury was alleged.The fluid was drained prior to removing the set from the warming unit.The employee reported biomed checked the warming unit prior to being put into service.The patient is reportedly stable.

• 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: 9072181
• Report Number: 2110898-2019-00105
• Device Sequence Number: 3069573
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

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: 10/08/2021
• Device Model Number: N/A
• Device Catalogue Number: 24365
• Device Lot Number: HW8238
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR