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

Model Number	802018
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the user facility's cardiovascular operating room lead, this event occurred during the initiation of cpb.No issues were noted during setup or during prior testing.The team attempted to initiate cpb, when venous blood was drained and it was noted that the perfusionist could not give forward flow.The team was delayed while troubleshooting how to restore forward flow.After 1-2 minutes, the team was able to provide forward flow and the pump was used for the remainder of the case.The surgery was able to continue with successful completion and the physician confirmed that the patient did not present with any deficits.There was loss of total blood volume to the bypass machine, due to forward flow being halted, that once reestablished, the volume was returned to the patient.The field service representative (fsr) could not duplicate the reported complaint.He tested the flow system and the unit passed testing.The unit operated to the manufacturer's specifications.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the unit had a back flow alarm and there was no forward flow.The surgical procedure was completed successfully.There was a short delay of about one to two minutes while troubleshooting.There was no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
The reported complaint was confirmed.Per data log analysis, the log indicated the issue likely occurred on 09feb2022.On that date there were multiple different pump speed setting changes followed by backflow alarms.The log confirms backflow alarms occurred but there was no indication of the cause.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 february 9, 2022, the team experienced a problem with the heart lung machine (hlm), whereby during initiation of bypass, they were unable to achieve forward flow, getting multiple backflow alarms.After 1-2 minutes, they were able to achieve forward flow and the case proceeded.There was no blood loss, no delay, and the surgery was completed successfully.The manufacturer's clinical specialist spoke with the user facility's biomedical technician and he was unable to provide specifics.The manufacturer's clinical specialist was unable to get in contact with the perfusionist.He then spoke with the field service representative (fsr) and the fsr indicated that he worked at length with the chief perfusionist to try to duplicate the problem, but they were unable to duplicate a backflow with the centrifugal motor drive or the medtronic adapter plate.Exhausting other possibilities, they discussed the very old, hospital-owned vacuum regulators being used for vacuum assisted venous drainage, and they discovered that it was set extremely high, and that likely it was turned on while initiating bypass, at a very high level.They then tested this theory and were able to duplicate backflow with the vacuum regulator turned on.They have since replaced the vacuum regulators and have continued to use the same hlm with no further issues.

• 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: 13637475
• Report Number: 1828100-2022-00079
• Device Sequence Number: 14752634
• Product Code: DTQ
• UDI-Device Identifier: 00886799000687
• UDI-Public: (01)00886799000687(11)201111
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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: 802018
• Device Catalogue Number: 802018
• 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: 02/10/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2020
• 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