MAUDE Adverse Event Report: 3M HEALTH CARE 3M RANGER(TM) HIGH FLOW BLOOD/FLUID 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 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation as of the date of this report.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 change 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 of the high flow disposable set.The change was implemented to increase strength and to minimize leaks.The reported lot in this event did include the solvent process change.3m continues to monitor their complaints to confirm the effectiveness of the change made and is also monitoring trends of complaints subsequent to the change.End of report.

Event Description

A hospital employee reported that a 3m(tm) ranger(tm) high flow blood/fluid disposable set leaked at the y connector.There was no reported patient injury.No information was provided as to when the leak occurred nor the type of fluid being used.

Manufacturer Narrative

Updated the report to include initial reporter name, e-mail and phone number and also full address of hospital.Also indicated more information about the use of product and when leak occurred.End of report.

Event Description

The leak occurred before it was attached to the patient and during priming.

• Brand Name: 3M RANGER(TM) HIGH FLOW BLOOD/FLUID 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: 6187433
• MDR Text Key: 62791049
• Report Number: 2110898-2016-00113
• Device Sequence Number: 1
• Product Code: BSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K973741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 24355
• Device Lot Number: HX7646
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2015
• 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