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

Model Number	6382
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per data log analysis, the system was powered up on (b)(6) 2022 and the flow module had sensor serial number (b)(4) attached.A perfusion screen was opened at 07:09:26 am.The flow sensor was disconnected and a different sensor was attached at 07:47:44 am (serial number (b)(4)).Starting at 07:48:21 am, many backflow alarms occurred.There was no way to tell from the log if actual backflow was occurring.The flow sensor was disconnected again and the original flow sensor serial number (b)(4) was connected at 07:52:05 am.The field service representative (fsr) verified the complaint.The flow readings would fluctuate during forward flow as reported.When the centrifugal control unit was stopped and at zero flow, the fluctuations still persisted and went positive and negative flow causing the reported intermittent back flow alarms.The fsr replaced the flow sensor.The unit operated to the manufacturer's specifications.During laboratory evaluation, the product surveillance technician (pst) was unable to test the sensor due to a damaged pin number six on the connector.This complaint is related to (b)(4) / mfr# 1828100-2022-00246.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
It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, the flow sensor had intermittent back flow alarms.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

• 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: 14835795
• Report Number: 1828100-2022-00247
• Device Sequence Number: 14045231
• Product Code: DTQ
• UDI-Device Identifier: 00886799000083
• UDI-Public: (01)00886799000083(11)210927
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 06/27/2022

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: 6382
• Device Catalogue Number: 6382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• 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: 06/02/2022
• Initial Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2021
• 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