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	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the manufacturer's subsidiary, the perfusionist found that the reservoir volume was increased even when the occluder was fully closed.It looked like the plunger was not coming out completely.This complaint is related to (b)(4) / mfr#1828100-2020-00424.
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the occluder did not fully occlude.As mitigation, manual occlusion was done using forceps.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Event or Problem Description
Additional information was received from the manufacturer's clinical specialist that the issue occurred during priming of the device.
Additional Manufacturer Narrative
H3: 81 evaluation is in progress, but not yet concluded.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) did not observe any issues.A functional test was performed on the occluder and observed no water level change in the tubing over time.
Additional Manufacturer Narrative
The reported complaint was confirmed based on a video that was sent in by the user but was unable to be duplicated during testing.The service repair technician (srt) could not duplicate the complaint.Testing was performed and the srt observed the occluder head to function as intended.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: 10874840
• Report Number: 1828100-2020-00446
• Device Sequence Number: 19548848
• Product Code: DTQ
• UDI-Device Identifier: 00886799000878
• UDI-Public: (01)00886799000878(11)190116
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K172220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/08/2021

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: 12/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 11/24/2020; 01/22/2021; 03/26/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/16/2020; 02/13/2021; 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1