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

Model Number	801764
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated block: b5.
Event or Problem Description
Per clinical review: the team at the user facility reported a problem with the heart lung machine (hlm) while on cardiopulmonary bypass, described as 'alarm occurred' with an explanation that the alarm occurred three times towards the end of bypass, with no message appearing on the main alarm message screen, and the user was unable to check the aux tab at the time of the occurrence to read the 'messages' tab, which would have indicated what the alarm was.There are several situations that can cause this behavior, namely an alarm event occurring and subsequently resetting so fast that the message does not appear on the main screen, but only appears on the 'message' screen in the aux tab.The most common are 'backflow' and 'level not attached'.It is thought the alarms were one of these possibilities, and not a false alarm, and normal hlm behavior.
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.
Additional Manufacturer Narrative
Per the manufacturer's technical support specialist, the data log showed a flow sensor back flow alarm.The user facility received guidance on the back flow alarm and the issue was resolved.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the central control monitor (ccm) alarmed around three times, but the user was unable to see what the message was on the ccm.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

• 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: 19411590
• Report Number: 1828100-2024-00145
• Device Sequence Number: 16947410
• Product Code: DTQ
• UDI-Device Identifier: 00886799000663
• UDI-Public: (01)00886799000663(11)230906
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2024

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: 801764
• Device Catalogue Number: 801764
• 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: 05/03/2024
• Supplement Date Received by Manufacturer: 06/10/2024; 07/02/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 07/02/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2023
• 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