MAUDE Adverse Event Report: 3M HEALTH CARE 3M RANGER BLOOD/FLUID WARMING SYSTEM STANDARD FLOW; STANDARD FLOW DISPOSABLE TUBING

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Electric Shock (2554)

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

Report source: 3m was notified on this adverse event by the (b)(6) health authority; incident #(b)(4).No sample was returned to 3m for evaluation.3m was unable to determine the exact location of the leak and identify the root cause without the sample.Based on the information provided, there appeared to have been a leak in the heat exchanger.Product lot b8339 was produced prior to implementation of corrective action.3m will continue to monitor.

Event Description

The (b)(6) health authority reported that an hcp in the (b)(6).Alleged a 3m¿ ranger¿ standard flow disposable set (model 24200) had a tear at the bottom right corner and leaked fluid into a 3m¿ ranger¿ warming unit.The hcp allegedly received a small electric shock while preparing the fluid.The employee reported no other equipment was nearby during preparation.The packaging was reportedly opened, and the cassette placed straight into the warmer.The warming unit was removed from use for maintenance.The hcp did not require treatment.

• Brand Name: 3M RANGER BLOOD/FLUID WARMING SYSTEM STANDARD FLOW
• Type of Device: STANDARD FLOW DISPOSABLE TUBING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul, mn
• 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; st. paul, mn ; 7379117
• MDR Report Key: 9712587
• MDR Text Key: 180358522
• Report Number: 2110898-2020-00013
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K973741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 24200
• Device Lot Number: B8339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2019
• 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