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

Model Number	806455
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) was unable to duplicate the reported complaint.There were no findings during initial inspection of physical appearance and connections for the system components.As a precaution, the fsr replaced the occluder and calibrated the central control monitor (ccm).The unit operated to the manufacturer's specifications.The suspect unit will be sent back to the manufacturer for further evaluation.This complaint is related to (b)(4) / medwatch #1828100-2020-00051.
Event or Problem Description
It was reported that during the use of the device for a cardiopulmonary bypass (cpb) procedure, the occluder did not completely open.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Event or Problem Description
Per clinical review: the manufacturer's clinical specialist tried to gather additional information from the perfusionist regarding the incident the team had with the venous occluder on the heart lung machine (hlm) during a cardiopulmonary bypass (cpb) procedure on (b)(6) 2020.It is not known if the occluder was calibrated prior to going on bypass for the procedure.The complaint states that the control on the central control monitor (ccm) for the occluder was moving up and down on its own.It was not able to confirmed or disconfirmed that the actual mechanical occluder was mimicking the software seen on the screen.Additionally, it was asked if the perfusionist was able to use the occluder, or if they reverted to using clamps.This mitigation was not answered.The team did not exchange the occluder during the procedure.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss associated with the event.
Additional Manufacturer Narrative
Updated blocks: b5 and d10.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) observed the occluder head to successfully calibrate and function as expected.The occluder was able to be opened and closed using the central control monitor.
Additional Manufacturer Narrative
Updated block: h6.The reported complaint was confirmed.The service representative technician was unable to duplicate the reported issue.He observed the occluder to function as intended through the evaluation.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
• MDR Report Key: 9723274
• Report Number: 1828100-2020-00067
• Device Sequence Number: 16225627
• Product Code: DTQ
• UDI-Device Identifier: 00886799000878
• UDI-Public: (01)00886799000878(11)190116
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/07/2020

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: 806455
• Device Catalogue Number: 806455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 02/13/2020; 05/01/2020; 10/07/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/09/2020; 05/22/2020; 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1