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

Model Number	PTC-1200
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The thermacor 1200 infusion system was used at (b)(6) on (b)(6) 2020.The hospital noticed the initial cassette had a twisted return line which caused limited flow for priming.The disposable cassette was changed out with a second cassette.After the surgery was completed, the hospital notice the second cassette was leaking from the bottom of the cassette.Both cassettes were from lot 313923.The cassette with the kinked return line was returned for investigation.It was determined that the yellow luer lock screw was tightened incorrectly.The yellow luer lock screw should be used to tighten but instead it appears that the clear base underneath was tightened.It appears that this incorrect tightening caused restricted flow.The second cassette, causing the reportable event, was not returned for investigation; however, based on the pictures submitted by the hospital, it appears the roller pump door tubing may have been pinched causing a leak at that area of the cassette.The surgery was delayed slightly due to the changing of the cassettes; however, no patient injury was noted.No issue has been noted for this lot of cassettes in the field.

• 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, 3rd floor; macon, ga
• MDR Report Key: 9996503
• Report Number: 3006158088-2020-00004
• Device Sequence Number: 11850983
• Product Code: FRN
• UDI-Device Identifier: 00857893006059
• UDI-Public: (01)00857893006059(10)313923(11)180419(17)230419
• Combination Product (Y/N): N
• 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): 04/02/2020

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 Expiration Date: 04/19/2023
• Device Model Number: PTC-1200
• Device Catalogue Number: PTC-1200
• Device Lot Number: 313923
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1