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 Problems Fluid/Blood Leak (1250); Appropriate Term/Code Not Available (3191)

Patient Problem Not Applicable (3189)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

No other information was provided.Initial reporter name, phone or e-mail was not provided.The product was returned for evaluation to 3m (b)(4) and is currently in route to (b)(6) for evaluation.The evaluation has not yet begun.Attempts are being made to obtain more information.End of report.

Event Description

A hospital employee alleged that a 3m¿ ranger ¿ high flow fluid warming set (model 24365) leaked liquid from the perimeter area.Type of liquid alleged to have leaked was not specified.No patient injury was alleged.No information was provided as to priming of the set or use of pressure devices.

Manufacturer Narrative

Device available for evaluation: date corrected to 6/12/2018.The product was received for analysis and photos were provided of alleged defective product.A review of photos provided and a visual inspection or product confirmed a fluid leakage at the heat exchanger perimeter.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 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 lot number indicated in this complaint would have been post cure-to-touch solvent bond process improvement.A new process improvement was implemented december 2017 to further reduce incidence of solvent bond leaks.3m continues to monitor their complaints to confirm the effectiveness of the change made.

• 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: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; tijuana baja california, MN 55144 ; 6517379117
• MDR Report Key: 7653434
• MDR Text Key: 112861309
• Report Number: 2110898-2018-00067
• Device Sequence Number: 1
• Product Code: BSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K973741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 24365
• Device Lot Number: HW7725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• 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