MAUDE Adverse Event Report: SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM; PUMP, INFUSION

Model Number	TIS-1200
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
All adult critical care units were transitioned to the thermacor for the rapid infusion of fluid and blood products in 2016.Prior to this change, another level 1 rapid infuser was used.This change was originally part of an initiative with labor and delivery, but the scope expanded as it was determined that the level 1 devices were aging and would be incompatible with new iv fluid bags brought in due to product shortages.Each icu received extensive in-servicing on the thermacor prior to implementation.This education has been continued by unit clinical nurse educators to maintain the ongoing competency of staff.Despite initial and on-going education efforts, several challenges using the thermacor? have emerged: patient safety concerns: use of the thermacor? has resulted in significant delays in the administration of blood components during life-threatening clinical conditions requiring massive and rapid transfusion.Blood and blood products are a precious commodity and each time a thermacor? set-up fails, a significant amount of blood is wasted.Staff safety concerns: users have been exposed to blood spray from cracked and easily disconnected tubing.Inefficient use of resources: for effective use, a minimum of 2 or 3 clinicians are required to manage the pump properly due to a high margin for error related to its design.The device is cumbersome to assemble and has large number of clamps and connections that make it vulnerable to air, slow flow rates and/or high-pressure alarms.Education challenges it is cost-prohibitive to use a new thermacor? kit for each episode of training on this low volume/high risk device.Therefore, hands-on training and simulation is difficult because the process of emptying the cassette and tubing for re-use is both time-consuming and complicated.Product representatives provided initial training sessions, as well as a second round of training sessions about 18 months ago in an effort to address user concerns.Device superusers were also identified on each unit, and the clinical nurse educators provide training on an on-going basis.Despite a heavy focus on re-education, the challenges described above have persisted.Manufacturer response for rapid infusing, (brand not provided) (per site reporter).Product representatives provided initial training sessions, as well as a second round of training sessions about 18 months ago in an effort to address user concerns.Device superusers were also identified on each unit, and the clinical nurse educators provide training on an on-going basis.Despite a heavy focus on re-education, the challenges described above have persisted.

• Brand Name: THERMACOR 1200 INFUSION SYSTEM
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMISSON-CARTLEDGE BIOMEDICAL, LLC; 487 cherry street; third street tower; macon GA 31201
• MDR Report Key: 8083972
• Report Number: 8083972
• Device Sequence Number: 1203531
• Product Code: FRN
• UDI-Device Identifier: 00857893006004
• UDI-Public: (01)00857893006004(11)170315
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2018
• Report Date (Section F): 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TIS-1200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/09/2018