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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation is in progress, but not yet concluded.Per the manufacturer's clinical specialist, the occluder head has been replaced.The suspect device has been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the occluder was not moving correctly.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the team set up the occluder and calibrated it without issue with a 1/2 by 3/32 venous line tubing for a procedure on (b)(6) 2018.When the team attempted to fill up the heart during weaning from cpb, the perfusionist stated that the occluder did not respond and clamped the line until it was greater than 80-85% closed.This was evident by the team not filling up the heart and the volume in the reservoir staying constant and not reducing.Because of the response they used a regular clamp to fully come off bypass.The incident with the occluder did not delay the continuation of the surgical procedure.There was no blood loss or harm associated with the event.
Additional Manufacturer Narrative
The reported complaint could not be confirmed.The service repair technician (srt) was unable to duplicate the reported complaint.The unit operates 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.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) observed no incorrect movement of the occluder.The occluder head was connected to the occluder module and connected to a system 1 simulator and central control monitor (ccm).A perfusion screen was entered and the occluder was calibrated.The plunger of the occluder head moved smoothly when using the open/close buttons, up/down arrows and the slider bar.There was no failure of the occluder head or occluder module during lab testing.
Additional Manufacturer Narrative
The field service representative (fsr) was unable to verify the reported complaint.He replaced the occluder head at the request of the clinical team.The unit operated to the manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.

• 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: 8101328
• Report Number: 1828100-2018-00605
• Device Sequence Number: 1098345
• Product Code: DTQ
• UDI-Device Identifier: 00886799000878
• UDI-Public: (01)00886799000878(11)180308
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/13/2019

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: 11/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 12/03/2018; 01/11/2019; 02/12/2019
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 12/16/2018; 01/31/2019; 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1