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

Model Number	802111
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the level detection module was not working properly.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated blocks: h3 and h6 the reported complaint was confirmed.On (b)(6) 2022, there were many instances of the alarm probe status changing from coupled to uncoupled, back to coupled.There were over (b)(4) instances of this on (b)(6) 2022.When the level detection is turned on this will always cause an audible alert.If the uncoupled condition last longer than 100 milliseconds (ms), a 'level not attached' alert will occur.The same behavior was observed in the logs on (b)(6) 2022 and (b)(6) 2022.Per the manufacturer's clinical specialist, after the heating/cooling unit was turned on and warmed up for prime, everything observed was fine for 29 minutes.He cycled the alert and alarm level sensors ten times, and each time the level detection system put the pump in coast or stop.Two minutes after doing the tests, they received a yellow unattached alarm.During the same testing on another day, the same alarm was received, but this time the red sensor was replaced with an older red sensor and the unit worked for 35 minutes without alarming.The sensor was used in a case with no issue.It was also noted that the sensor pads were not manipulated.The field service representative (fsr) was unable to duplicate the reported complaint.He replaced the module as requested by the manufacturer's sales representative and it was release tested.The unit operated to the manufacturer's specifications.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: 13550169
• Report Number: 1828100-2022-00063
• Device Sequence Number: 5236188
• Product Code: DTQ
• UDI-Device Identifier: 00886799000717
• UDI-Public: (01)00886799000717(11)211103
• 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
• Report Date (Section B): 03/11/2022

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: 802111
• Device Catalogue Number: 802111
• 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: 01/31/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• 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