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

Model Number	195240
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint is related to (b)(4)/ mfr #1828100-2020-00326.
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the level sensor pads were not sticking to the venous reservoir and were causing an alarm.As a result, an alternate device was employed.There was no delay, no blood loss, nor adverse consequences to the patient.No other details regarding the nature of this event were provided.Per clinical review: there was no additional information available regarding the level sensing system incident that occurred during a cpb procedure on (b)(6) 2020.According to the obtained information, the level sensing system alarmed two times during a procedure, and the team proceeded to exchange the level sensing pads.It was not known what type of reservoir system the team used.This did not delay the continuation of the surgical procedure.There was no harm or blood loss associated with the event.
Additional Manufacturer Narrative
The reported complaint was not verifiable.Multiple diligence attempts for part return were unsuccessful so an evaluation could not be completed.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
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 10464666
• Report Number: 1828100-2020-00328
• Device Sequence Number: 3092610
• Product Code: DTQ
• UDI-Device Identifier: 10886799001704
• UDI-Public: (01)10886799001704(17)211130(10)918264
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K022947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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 Expiration Date: 11/30/2021
• Device Model Number: 195240
• Device Catalogue Number: 195240
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1