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

Model Number	195274
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) replaced the level sensor.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 red level sensor gave erroneous alarms.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, blood loss, nor adverse consequences to the patient.
Event or Problem Description
Per clinical review: on (b)(6) 2022, the team experienced a problem with their heart lung machine (hlm) whereby they got erroneous alarms from the level sensor.There was no delay or blood loss, and the surgery was completed successfully.The manufacturer's clinical specialist confirmed with the perfusionist involved in this incident that there was no change out while on cardiopulmonary bypass.He stated that after replicating the alarm with a primed circuit (not involving a patient case), he changed out the red level sensor and it then functioned correctly.
Additional Manufacturer Narrative
Updated blocks: b5 and d9.During laboratory analysis, the product surveillance technician (pst) observed that with the red level sensor attached to lab use only (luo) testing equipment, the sensor passed all testing and ran for 3.5 hours with no observation of any erroneous alarms.The sensor operated as intended.
Additional 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
• 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: 14112355
• Report Number: 1828100-2022-00151
• Device Sequence Number: 19370165
• Product Code: DTQ
• UDI-Device Identifier: 00886799000496
• UDI-Public: (01)00886799000496(11)210902
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Followup
• Report Date (Section B): 07/21/2022

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: 195274
• Device Catalogue Number: 195274
• 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: 03/22/2022
• Supplement Date Received by Manufacturer: 04/22/2022; 06/30/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 05/13/2022; 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• 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