MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number	802114
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) verified that the temperature module was operating properly and the user facility was using a bad cable.The user replaced the cables and the temperature sensor then worked.The unit operated to the manufacturer's specifications.
Event or Problem Description
It was reported that the temperature cables were not working.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.No other details regarding the nature of this event were provided.
Event or Problem Description
Additional information was received that the issue occurred during set-up of the device for a cardiopulmonary bypass (cpb) procedure.
Additional Manufacturer Narrative
Per data log review, the temperature log starts on (b)(6)2021 and the system was left powered on until the complaint reported date (b)(6)2021.On (b)(6)2021 the channel 1 sensor state was frequently changing from connected in range to under range and/or disconnected.Similar behavior occurred on (b)(6)2021 on channels 1 and 2.On the date the issue was reported ((b)(6)2021), the channel 1 probe was connected at 08:01:18 am and disconnected at 01:01:55 pm with no state changes in between.The system powered off at 01:28:33 pm.
Additional Manufacturer Narrative
The reported complaint was confirmed.The cable that failed is supplied by another manufacturer and does not meet the requirements for use with the temperature module in question.The temperature module was operating to the manufacturer's specifications.The field service representative provided additional guidance to the end user on which cable to use.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: ADVANCED PERFUSION SYSTEM 1
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 11777579
• Report Number: 1828100-2021-00160
• Device Sequence Number: 19940336
• Product Code: DTQ
• UDI-Device Identifier: 00886799000748
• UDI-Public: (01)00886799000748(11)191212
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K172220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2021

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 Model Number: 802114
• Device Catalogue Number: 802114
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 05/18/2021; 06/10/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/09/2021; 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1