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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the user facility's biomedical technician, the issue persisted even after the flow sensor was swapped out.The field service representative (fsr) could not duplicate the reported complaint.The fsr replaced the flow module and flow sensor.The unit operated to the manufacturer's specifications.
Event or Problem Description
It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, the flow reading was fluctuating.As a result, an alternate device was employed.No other details regarding the nature of the event were provided.
Additional Manufacturer Narrative
Per data log review: the log showed on 23mar2022, the last time the system was used, multiple occurrences of the sensor coupling to the tube with fluid.It is possible that this caused the flow to fluctuate as reported.Measured flow was not logged and there is no way to tell from the log if the measured flow matched the actual flow.
Additional Manufacturer Narrative
The reported complaint could not be confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
Updated.
Additional Manufacturer Narrative
The reported complaint could not be confirmed.During laboratory evaluation, the product surveillance technician connected the flow module to lab use only testing equipment.He found the flow module to pass all release testing and monitored the flow for two hours and observed little variance (less than 10%) in the flow reading.The flow module operated as expected.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: 14112195
• Report Number: 1828100-2022-00150
• Device Sequence Number: 4794136
• Product Code: DTQ
• UDI-Device Identifier: 00886799000687
• UDI-Public: (01)00886799000687(11)191211
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/29/2022

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: 05/18/2022
• Supplement Date Received by Manufacturer: 09/22/2022; 09/22/2022; 09/22/2022; 09/22/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 06/08/2022; 07/07/2022; 09/12/2022; 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2019
• 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