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	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Field service representative (fsr) collected the logs and they are currently under review to troubleshoot the issue.
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the occluder head displayed a 'venous occlusion needs to be recalibrated' message.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the venous occluder was calibrated and used during a cpb procedure on (b)(6) 2020.Towards the end of the procedure the user was given a venous occlusion recalibration message, and the device totally occluded the venous line from the patient.The perfusionist stated that she lost all of her drainage, but she was able to open the venous occluder and use manual clamps for the remainder of the procedure.This issue did not delay the continuation of the surgical procedure.There was no harm or blood loss associated with the event.
Additional Manufacturer Narrative
Per data log analysis, the complaint indicates the issue occurred on (b)(6) 2020, but the log indicates the issue occurred on (b)(6) 2020.On (b)(6) 2020 a perfusion screen is opened at 6:44:37 am.When the occluder was initially calibrated the 0% linear position was 1737.At 9:30:10 am the 0% linear position is now 1636 indicating the plunger extended a little further than at calibration.At 10:46:41 am the 0% position is now 928.This is low enough to suggest that the tube was possible removed.This also sets the 0% position to this new lower value.At 12:13:03 pm the occluder slider was moved from 100% and at 85% an unexpected stall occurs at linear position 1633.This indicates the tube may have been installed again.This will cause the reported issue where calibration is lost.The log cannot confirm 100% that the tube was removed and re-installed, but that is the indication that would cause the reported issue.
Additional Manufacturer Narrative
The reported complaint was confirmed via the data logs.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
• MDR Report Key: 9712380
• Report Number: 1828100-2020-00056
• Device Sequence Number: 2001711
• Product Code: DTQ
• UDI-Device Identifier: 00886799000779
• UDI-Public: (01)00886799000779(11)181107
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2020

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: 01/20/2020
• Supplement Date Received by Manufacturer: 02/14/2020; 03/13/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/09/2020; 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1