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	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter's name and email address was not provided.Initial reporter occupation was not provided.The product has not been received by 3m (b)(4) for evaluation.A product photo reflecting the leakage location was provided.Upon observation, there appeared to be a leak from a crack in the bubble trap.Supplier corrective action request number (b)(4) was issued last year (2018) for high flow bubble trap leaks.A request was sent to supplier to obtain first lot implementation information to verify if reported lot was produced before or after implementation.3m will continue to monitor.Analysis of returned product sample is pending.A follow up report will be submitted upon completion of analysis.Multiple attempts have been made to obtain more information on reported incident.End of report.
Event or Problem Description
A hospital employee alleged that a 3m¿ ranger ¿ high flow fluid warming set (model 24365) leaked whole blood from a crack in the bubble trap while pumping.Further details regarding usage of the device were not specified.No patient injury or harmful exposure to blood was alleged.

• 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: 8537468
• Report Number: 2110898-2019-00051
• Device Sequence Number: 400406
• Product Code: BSB
• UDI-Device Identifier: 00707387781460
• UDI-Public: 00707387781460
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K973741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2019

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: 05/23/2021
• Device Model Number: N/A
• Device Catalogue Number: 24365
• Device Lot Number: HW8164
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other