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

Model Number	803480
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's clinical specialist visited on-site to address the perfusionist was having with the occluder.It was found during this time that the issue was use related and no service was required by the field service representative (fsr).
Event or Problem Description
It was reported that the occluder was not calibrating.No other details regarding the nature of this event were provided.
Additional Manufacturer Narrative
Updated blocks: b5 and h6.The reported complaint was confirmed.Per the manufacturer's clinical specialist, the perfusionist noticed that the tubing was partially occluded in the occluder even though it was set at full open.He did not realize that this was normal, meaning that the tubing was slightly occluded even at full open in order to hold the tubing in place.The perfusionist decided to remove the tubing from the occluder head and felt that venous drainage improved which was communicated to the surgeon who then believed something was wrong with occluder.The clinical specialist re-explained the safety connections to the perfusion team as well as reviewed the operation, calibration, and use of the occluder.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
Additional information received that the issue happened during setup.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
• MDR Report Key: 9712582
• Report Number: 1828100-2020-00059
• Device Sequence Number: 11262951
• Product Code: DTQ
• UDI-Device Identifier: 00886799000779
• UDI-Public: (01)00886799000779(11)190830
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K172220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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: 803480
• Device Catalogue Number: 803480
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1