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

Model Number	PTC-1200
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The thermacor 1200 rapid infusion system was being used at (b)(6), and during a procedure, the hospital stated the cassette started leaking from the bottom of the cassette.The hospital changed out the cassette in order to continue the surgery.No patient injury or extended time to surgery was noted by the hospital.The cassette was returned by the hospital, and the investigation was completed.The adhesive bonding was not secure at two locations - 1) tubing that attached to the filter for the pressure port was not secure, and 2) the filter to the pressure port was not secure.Both of these locations use adhesive for securing the parts together.The dhr was reviewed and no issue was noted during assembly or during leak testing.The final cassette assembly is pressure decay tested, and this lot did not indicate any leaks.The retain sample was tested and no issue was noted.The retain sample was opened, and the connections were secure on the filters and the tubing and the filters to the pressure ports.No issue has been noted for this lot of cassettes in the field.There is no inventory left available for this lot of cassettes.
Additional Manufacturer Narrative
Complaint (b)(4).

• 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 31201
• Manufacturer Contact: donna stevenson ; 487 cherry street; third street tower, 3rd floor; macon, GA 31201 ; 4783306205
• MDR Report Key: 13715546
• Report Number: 3006158088-2022-00001
• Device Sequence Number: 17713811
• Product Code: FRN
• UDI-Device Identifier: 00857893006059
• UDI-Public: (01)00857893006059(10)311754(11)171201(17)221201
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2022

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: 12/01/2022
• Device Model Number: PTC-1200
• Device Catalogue Number: PTC-1200
• Device Lot Number: 311754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown