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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the alarm level sensor had intermittent alarm failures.No other details regarding the nature of this event were provided.
Additional Manufacturer Narrative
Updated blocks: b3, b5, d4, d9, h3, h4 and h6 during laboratory analysis, the product surveillance technician (pst) connected the level sensor to lab use only (luo) testing equipment.It was monitored for over six hours and there were no observations of intermittent alarm failures.Release testing passed successfully.It was determined that the level sensor met specification.
Event or Problem Description
Additional information was received that the event occurred during cardiopulmonary bypass (cpb).The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: on 25mar2022, the team experienced a problem with their heart lung machine (hlm) while on cpb, described as intermittent level alarm failures.The problem was mitigated by disconnecting the level sensor and not using it for the duration for the case, which was completed successfully with no delay, no blood loss, and no adverse outcome.
Additional Manufacturer Narrative
Updated block: h6 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: 14166051
• Report Number: 1828100-2022-00156
• Device Sequence Number: 11960582
• 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): 06/10/2022

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: 05/18/2022
• Supplement Date Received by Manufacturer: 06/10/2022; 06/10/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 06/08/2022; 06/10/2022
• 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