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	03/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the venous temperature probe stopped working.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the team reported an issue with their heart lung machine (hlm) during cpb.Specifically, the venous temperature probe stopped working during a case.The probe was switched to be plugged into the arterial port on the module, and readings were able to be taken.The case was able to continue and be completed using the arterial readings from the blood parameter monitor (bpm) and venous readings from the arterial port of the module.It appeared to just be the venous port on the temperature module that stopped functioning.The surgery was completed successfully.There was no delay.The unit was not changed out, no blood loss and no adverse event reported.
Additional Manufacturer Narrative
Per the manufacturer's field service representative (fsr) the perfusionist noticed that a probe was not fully inserted into the port.When the probes were plugged in it was observed that they were in the wrong ports, so the probes did not correspond to the correct central control monitor (ccm) temperature locations.The probes somehow swapped locations between the two modules.Their screen was configured for only three temperature probes, so they were trying to plug in into a port that was not attached to a location on the ccm screen.Once the probes were put into their proper location, the issue resolved.The units passed release testing.The unit operated to the manufacturer's specifications.
Additional Manufacturer Narrative
The reported complaint was confirmed.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: 16612185
• Report Number: 1828100-2023-00088
• Device Sequence Number: 4931466
• Product Code: DTQ
• UDI-Device Identifier: 00886799000748
• UDI-Public: (01)00886799000748(11)191202
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 05/01/2023

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?: Yes
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2019
• 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