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	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tubing set was returned for investigation.The 3 spike set received was tested, and leaking did occur around the end cap at the solvent bonding.The 3 spike set was returned to the manufacturer.The dhr was reviewed for this lot; no issue was noted.The manufacturer currently 100% leak tests all 3 spike sets.It is unsure how this set was not deemed as a leaker during production.No other issue of this type has been noted for the 3 spike sets.(b)(4).
Event or Problem Description
The thermacor 1200 infusion system was being used at (b)(6) on (b)(6) 2019.The hospital stated the 3 spike set (tubing set for the ptc-1200) started leaking blood during surgery.The 3 spike set was changed out, and the surgery continued with the thermacor 1200 system.No patient injury or extended surgery time was needed for changing out the 3 spike set.

• 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 floo; macon GA 31201
• MDR Report Key: 9126145
• Report Number: 3006158088-2019-00001
• Device Sequence Number: 19426647
• Product Code: FRN
• UDI-Device Identifier: 00857893006110
• UDI-Public: (01)00857893006110(10)314104(11)180515(17)230515
• 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): 09/05/2019

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 Expiration Date: 05/15/2023
• Device Model Number: PTC-1200
• Device Catalogue Number: PTC-1200
• Device Lot Number: 314104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1