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

Model Number	TIS-1200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Scb representatives were sent to the hospital to test all six units at the hospital.All units passed without any high temp messages.Unit (b)(4) passed testing, but it was determined to have the unit returned for further testing.The unit passed the standard incoming inspection; however, testing was also performed using heated fluid to 45 degree celsius and also 50 degree celsius.On each of these occasions, the unit exhibited "hi temp 3" error message.The unit performed as it was intended.This error message indicates the temperature of the fluid was too warm for patient safety.The unit would not allow the warmer fluids (above 45 degree) to be administered to the patient.When discussing with the hospital, it was confirmed that they were using a warming cabinet for the fluids prior to using with the thermacor 1200.It was determined that the thermacor 1200 infusion system worked properly.Further training will take place at the hospital on october 1, 2019 through october 3, 2019.
Event or Problem Description
The thermacor 1200 infusion system was being used at (b)(6).The unit exhibited "hi temp" error message.The unit was power cycled in order to clear the error message; however, this was unsuccessful.The hospital had to squeeze bags until the surgery was completed.No patient injury was noted by the hospital.

• Brand Name: SMISSON-CARTLEDGE BIOMEDICAL, LLC
• Common Device Name: THERMACOR 1200 INFUSION SYSTEM
• Manufacturer (Section D): SMISSON-CARTLEDGE BIOMEDICAL, LLC; 487 cherry street; third street tower, third fl; macon GA 31201
• MDR Report Key: 9152714
• Report Number: 3006158088-2019-00002
• Device Sequence Number: 14148709
• Product Code: FRN
• UDI-Device Identifier: 00857893006004
• UDI-Public: (01)00857893006004(11)181213
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K052055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TIS-1200
• Device Catalogue Number: TIS-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1