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

Model Number	PNC-1200
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Scb complaint number - (b)(4).
Event or Problem Description
During surgery at (b)(6) memorial hospital, the staff noticed the cassette started leaking blood at the patient line connection to the cassette.The cassette lot number was lot 316277.The hospital changed over to a level one unit to complete the surgery.No patient harm was noted by the hospital.The tubing was returned to the distributor, medical solutions, inc (msi).Msi found no adhesive at the cassette end of the patient line which caused the leak at the fitting.Retains were reviewed, and adhesive was present at the connection.No other issues have been noted for this lot.The dhr was reviewed; no issue was noticed for this lot.The manufacturer has been notified of the issue.

• 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: 10568031
• Report Number: 3006158088-2020-00006
• Device Sequence Number: 19727317
• Product Code: FRN
• UDI-Device Identifier: 00857893006066
• UDI-Public: (01)00857893006066(10)316277(11)181105(17)231105
• 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): 09/22/2020

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: 11/05/2023
• Device Model Number: PNC-1200
• Device Catalogue Number: PNC-1200
• Device Lot Number: 316277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1