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.Date of event: the customer reported the incidents occurred on (b)(6) 2019.Leakage location has not been verified and root cause has not been established.The sample has not been received by 3m st.Paul, mn for evaluation.Analysis is pending on returned samples to verify leakage location.3m is attempting to obtain further information from the customer.End of report.
Event or Problem Description
A hospital employee alleged a 3m¿ ranger¿ high flow disposable set (model 24365) leaked fluid from the side of the auto venting bubble trap.The employee alleged second set was discovered to have a kink below the auto venting bubble trap.The cassette reportedly burst inside the ranger¿ warming unit.The warming unit was sent to biomed.No patient or staff injury was alleged.No further 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: 9309246
• Report Number: 2110898-2019-00133
• Device Sequence Number: 2373773
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2019

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: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 24365
• Device Lot Number: HW8255
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1