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

Model Number	PTC-1200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The thermacor 1200 rapid infusion system was being used at (b)(6) medical center for a mass blood transfusion.During the procedure, the hospital stated the cassette started leaking from the bottom of the cassette.The hospital immediately switched to pressure bags.The patient was taken to the or where a second thermacor unit was used.Due to the location of the leak, it appears the hospital staff positioned the tube incorrectly in the roller pump which caused the pinched tubing and leakage.The retain sample was tested and no issue was noted.No issue has been noted for this lot of cassettes in the field.The cassette was not returned by the hospital which no further investigation could be performed on the leaking cassette.
Additional Manufacturer Narrative
(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
• MDR Report Key: 12668484
• Report Number: 3006158088-2021-00002
• Device Sequence Number: 4232987
• Product Code: FRN
• UDI-Device Identifier: 00857893006059
• UDI-Public: (01)00857893006059(10)316833(11)190124(17)240124
• 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): 10/20/2021

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: 01/24/2024
• Device Model Number: PTC-1200
• Device Catalogue Number: PTC-1200
• Device Lot Number: 316833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1