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

Model Number 816572

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2023

Event Type  malfunction  

Manufacturer Narrative

Per the field service representative (fsr), the perfusionist was uncertain of the cause of the issue at the time of the event, but wanted to have the centrifugal system checked to ensure all possible factors were accounted for.The fsr tested the centrifugal system and the pump passed all release testing.A review of the log data also showed no issues with the centrifugal pump.The unit operated to the manufacturer's specifications.Per data log review: based on the pump log there were no issues seen with the centrifugal pump.It was configured to stop for air bubble detection and low level alarm; coast for low level alert and pressure; and message only for pressure alert and back flow.There were no events seen that would cause the pump to trigger, only normal user starting and stopping the pump.The system log showed the pump revolutions per minute (rpm) went below coast, by the user.There were no alarms or alerts.The pump was stopped and started several times around 11:20 am; the pump rpm was below 1500rpm which is the coast mode and may not be enough rpm depending on the circuit.

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the centrifugal system had no forward flow.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was a blood loss of approximately 1.5 liters (l).There was no delay, nor adverse consequences to the patient.

Event Description

Per clinical review: on (b)(6) 2023, the team experienced a potential problem with their heart lung machine (hlm) centrifugal control unit (ccu) during cardiopulmonary bypass (cpb), in that the team was unable to get forward flow from the centrifugal pump.The pump was changed out, with approximately 1.5 liters (l) of blood loss, no reported delay, and no injury to the patient.According to the field service representative (fsr), it was concluded that no manufacturer product contributed to the incident and that the service call was made as a matter of due diligence to confirm there was no problem with the centrifugal pump.

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
• Type of Device: 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: 17213316
• MDR Text Key: 318005954
• Report Number: 1828100-2023-00178
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001387
• UDI-Public: (01)00886799001387(11)210107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 816572
• Device Catalogue Number: 816572
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention