MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RANGER¿ HIGH FLOW 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	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient injury nor patient information provided.The reported issue was discovered prior to use on a patient.Device was returned for evaluation.Device evaluation is anticipated, but has not begun.A product photo provided from the customer verified a y-connector solvent bond leak.Device manufacturing start date is 2/27/2017.3m implemented a new dehp free material to enhance the material properties on all 3m ranger(tm) fluid warming disposable products in 2013.Subsequent to this change 3m received a higher trend of complaints applicable to leaks within selected areas of the disposable tubing connections.3m implemented a solvent improvement process in late 2015 to address this type of event.This improvement was to the solvent bond process to reduced leaks on all of the following areas; y-connector, drip chamber, bubble trap and tube fitting which are part of the high flow disposable set.The change was implemented to increase strength and to minimize leaks.The lot number indicated in this complaint would have been post cure-to-touch solvent bond process improvement.New process improvement implemented (b)(3) 2017 to further reduce incidence of solvent bond leaks on all of the following areas; y-connector, drip chamber, bubble trap and tube fitting which are part of the high flow disposable set.
Event or Problem Description
A hospital employee reported use of a 3m¿ ranger¿ high flow disposable set.The employee alleged that the warming unit leaked saline fluid at the at the luer connection area.A photo of the product was provided which reflected a y-connector solvent bond leak.The leak was discovered, during priming, prior to being used on a patient.The fluid was being warmed at 15-20 degrees celsius.A pressure infusor was being used at the time.No patient injury was alleged.

• Brand Name: 3M¿ RANGER¿ HIGH FLOW 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: 7679368
• Report Number: 2110898-2018-00073
• Device Sequence Number: 19178471
• Product Code: BSB
• UDI-Device Identifier: 50608223243553
• UDI-Public: 50608223243553
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K973741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2018

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: 02/27/2020
• Device Model Number: N/A
• Device Catalogue Number: 24355
• Device Lot Number: HX7897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 07/11/2018
• 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