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	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the manufacturer's subsidiary, the user facility tried to open the occluder by using the ccm control, but suddenly the occluder fully occluded itself.They tried to open the occluder by pressing the fully open button on the ccm, but it would not work and appeared to be freezing the occluder head.The subsidiary replaced the occluder module.
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the occluder head would close by itself.They continued the procedure by opening the occluder cover and using manual clamps.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the team had an incident with the control of the occluder from the central control monitor (ccm) on the heart lung machine (hlm) during cpb on (b)(6) 2021.The team calibrated the occluder prior to the case.They initiated cpb without issue.The team was then asked to fill up the patient a bit (tried to give volume by occluding the occluder a bit on the venous line).They tried to do this with the slider on the ccm and it went to fully occluded.The team had to manually use clamps to perform this command.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: d4, d9, h3, h4 and h6.During laboratory analysis, the product surveillance technician (pst) observed the occluder module to function as intended when connected to a lab use only (luo) occluder head.The occluder module was monitored for five hours and the pst did not observe the occluder to close on its own.Microscopic examination of the module circuit boards was conducted and no abnormalities were found.The module passed release testing.
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.

• 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: 11921306
• Report Number: 1828100-2021-00200
• Device Sequence Number: 10999990
• Product Code: DTQ
• UDI-Device Identifier: 00886799000878
• UDI-Public: (01)00886799000878(11)180308
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2021

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: 803480
• Device Catalogue Number: 803480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/28/2021; 07/20/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/19/2021; 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1