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

Model Number	5785
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per data log review: the data log review showed that the central control monitor (ccm) lost the air bubble detector (abd) module status several times.The abd log showed that the module went through power cycles several times which could be a connection issue between the abd and the network interface card (nic) or it could be an intermittent abd.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the air bubble detector (abd) was attached to the cerebral perfusion line and the air alarm occurred even when it was off.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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.
Event or Problem Description
Per clinical review: on (b)(6) 2024, the team experienced a problem with their heart lung machine (hlm) during cardiopulmonary bypass (cpb) whereby an air bubble detector (abd) alarm occurred even when it was turned off.According to the user, when the air sensor was attached to the cerebral perfusion line, the air alarm occurred even when it was off.It occurred when the cerebral perfusion line was connected to the operating field circuit and priming was performed.They finished the case without changing out the abd.There was no delay to the procedure, no blood loss, or adverse event reported.

• 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: 20561918
• Report Number: 1828100-2024-00303
• Device Sequence Number: 18391387
• Product Code: DTQ
• UDI-Device Identifier: 00886799000045
• UDI-Public: (01)00886799000045(11)200417
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022947
• 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): 02/04/2025

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: 5785
• Device Catalogue Number: 5785
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 12/17/2024; 01/29/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/08/2025; 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2020
• 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