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	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the perfusionist, the backflow alarm was intermittent and frequent even when the lines were separated at the field and clamped and the tubing at the pump was clamped.There was no flow present and the flow probe was still alarming.The team does not do retrograde autologous prime (rap).The perfusionist replaced the flow probe and the problem persisted with only prime in the circuit, no blood.He moved the clamps around to try and silence the alarm but that did not work.He then moved the flow probe to the tubing off of the arterial outlet from the oxygenator where the tubing divided to the arterial arm and the recirculation line.It appeared to be silenced during that time with movement through the flow probe.But when there was no movement of fluid through the flow probe, it would alarm.The perfusionist went on bypass and the flow probe seemed to be working well with no alarm and the correct rate per minute (rpm) flow was reading on the centrifugal pump.
Event or Problem Description
It was reported that prior to use of the device for a cardiopulmonary bypass (cpb) procedure, there were constant backflow alarms.As a result, an alternate device was employed.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 via a photograph from the user facility showing the backflow messages received on the central control monitor (ccm).Multiple diligence attempts for part return were unsuccessful so no further evaluation or root cause analysis could be completed.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: 12660112
• Report Number: 1828100-2021-00375
• Device Sequence Number: 17356520
• Product Code: DTQ
• UDI-Device Identifier: 00886799000687
• UDI-Public: (01)00886799000687(11)180514
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 12/10/2021

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: 10/01/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OXYGENATOR; OXYGENATOR
• Patient Sex: Unknown