MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RANGER¿ HIGH FLOW DISPOSABLE SET; HIGH FLOW DISPOSABLE TUBING

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Not Applicable (3189)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

No patient injury nor patient information provided after attempts to obtain information.Device manufacturing start date is 5/31/2016.3m 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 dec, 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.End of report.

Event Description

A hospital employee reported use of a 3m¿ ranger¿ high flow disposable set.The employee alleged that the warming unit leaks fluid at the "y" connector tubing on top periodically.No patient injury was alleged.

• Brand Name: 3M¿ RANGER¿ HIGH FLOW DISPOSABLE SET
• Type of Device: HIGH FLOW DISPOSABLE TUBING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): NYPRO PRECISION ASSEMBLIES; sor juana ines de la cruz; cd. industrial; tijuana, tijuana baja california 22444 ; MX 22444
• Manufacturer Contact: linda johnsen ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517374376
• MDR Report Key: 7534294
• MDR Text Key: 109007570
• Report Number: 2110898-2018-00056
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 50608223243553
• UDI-Public: 50608223243553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 24355
• Device Lot Number: HX7756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other