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	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the centrifugal controller unit (ccu) was giving a false backflow alarm.As a mitigation, the sensor was unplugged.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: on (b)(6) 2022, the team at the user facility experienced a problem with the heart lung machine (hlm) whereby a 'backflow alarm kept going off for no reason'.The manufacturer's clinical specialist spoke at length with the perfusionist who explained that the problem happened periodically, always with the same hlm, but not every case.He said the backflow alarm does not happen while on cpb, but during the time of no flow just before or just after cpb.He also explained that when this backflow alarm was occurring, the only way to make it stop was to unplug the sensor.The surgery was completed successfully with no delay, no blood loss, and no change out.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the centrifugal controller unit (ccu) was giving a false backflow alarm.As a mitigation, the sensor was unplugged.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: on (b)(6) 2022, the team at the user facility experienced a problem with the heart lung machine (hlm) whereby a 'backflow alarm kept going off for no reason'.The manufacturer's clinical specialist spoke at length with the perfusionist who explained that the problem happened periodically, always with the same hlm, but not every case.He said the backflow alarm does not happen while on cpb, but during the time of no flow just before or just after cpb.He also explained that when this backflow alarm was occurring, the only way to make it stop was to unplug the sensor.The surgery was completed successfully with no delay, no blood loss, and no change out.
Additional Manufacturer Narrative
Updated blocks: d4 and h4 per the manufacturer's sales manager, new replacement parts were ordered by the user facility.
Additional Manufacturer Narrative
Updated blocks: d9, h3 and h6 the reported complaint could not be confirmed.Per log review, the issue was reported to have occurred on 02-feb-2022.The flow module was returned for repair but when the log was exported it only went back to 08-apr-2022.The complaint cannot be confirmed with the log since the log does not cover the date the issue occurred.The flow sensor that was also returned was part number: 6382, serial number: 4210, udi: (b)(6)during laboratory evaluation, the product surveillance technician (pst) connected the flow module and flow sensor to the lab use only (luo) testing equipment.Both passed all verification and release testing.The pst monitored for inadvertent backflow alarms and made no observations and passed for a period of six hours.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: 13598852
• Report Number: 1828100-2022-00075
• Device Sequence Number: 14916980
• Product Code: DTQ
• UDI-Device Identifier: 00886799000687
• UDI-Public: (01)00886799000687(11)190904
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 05/27/2022

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?: Device Returned to Manufacturer
• 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: 02/02/2022
• Supplement Date Received by Manufacturer: 04/13/2022; 05/26/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 05/06/2022; 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2019
• 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