MAUDE Adverse Event Report: SMISSON-CARTLEDGE BIOMEDICAL, LLC SMISSON-CARTLEDGE BIOMEDICAL, LLC; THERMACOR 100 INFUSION PUMP

Model Number	PTC-1200
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The thermacor 1200 infusion system was used at (b)(6) hospital.After 1 1/2 hours into the surgery, the hospital noticed the thermacor unit was not infusing blood.It was stated that the lack of infusion was due to the twisted return line on the cassette.The cassette was changed out with a second cassette.The hospital did encounter problems removing the first cassette due to the way the initial cassette return line had been connected to the 3 spike set.The first cassette was returned for investigation.It was determined that the yellow luer lock screw was connected and 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 and twisting caused restricted flow.The retain sample was reviewed for any issue of this type; the retain sample was tested and no issue was noted.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.Reviewing past history of complaints for (b)(6) hospital, it was noted that this same type of issue was noted in 2017.Medical solutions (msi), distributor for smisson-cartledge biomedical, discussed the issue with the biomed at the hospital.The hospital was informed that the kinked or twisted return line would cause limited flow rate or error code, "unclamp return line".Msi also informed the biomed that the return line is not a quick disconnect, and it is recommended that the yellow screw lock should be used to tighten and connect the cassette onto the 3 spike set return line.To further eliminate the issue, the endcap has been changed to a green cap.The green cap should be removed and the yellow screw lock should be used to tighten and connect the cassette onto the 3 spike set return line.Msi has offered more training if needed by the hospital.

• Brand Name: SMISSON-CARTLEDGE BIOMEDICAL, LLC
• Common Device Name: THERMACOR 100 INFUSION PUMP
• Manufacturer (Section D): SMISSON-CARTLEDGE BIOMEDICAL, LLC; 487 cherry street; third street tower, 3rd floor; macon GA 31201
• MDR Report Key: 10870096
• Report Number: 3006158088-2020-00007
• Device Sequence Number: 14112146
• Product Code: FRN
• UDI-Device Identifier: 00857893006059
• UDI-Public: (01)00857893006059(10)317051(11)190218(17)240218
• 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): 11/19/2020

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: 02/18/2024
• Device Model Number: PTC-1200
• Device Catalogue Number: PTC-1200
• Device Lot Number: 317051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1