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	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) installed a new temperature module.Verification/release testing passed successfully.The unit operated to the manufacturer's specifications.
Event or Problem Description
It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, the temperature module was flashing yellow and then turned red.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) connected the temperature module to lab use only (luo) testing equipment.It was powered on and passed release testing successfully.Both connection ports were tested and passed successfully.The temperature module was monitored for 49 hours with no observation of any issues.The housing extension of the module was found to be detached but did not appear to affect the functionality of the module.It was determined that the temperature module operated as intended.
Additional Manufacturer Narrative
The reported complaint was confirmed.Per data log review: the logs that were provided were exported on (b)(6) 2022.The issue occurred on (b)(6) 2022.The system log (central control monitor (ccm)) only went back to (b)(6) 2022 and did not cover the incident date.The suspect temperature module was replaced before exporting the logs so there was no log data.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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 15719265
• Report Number: 1828100-2022-00375
• Device Sequence Number: 11492967
• Product Code: DTQ
• UDI-Device Identifier: 00886799000748
• UDI-Public: (01)00886799000748(11)190325
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 11/16/2022; 12/22/2022
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 12/08/2022; 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown