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

Model Number	802112
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) could not find any issues with the level or pressure sensors and the reported complaint could not be duplicated.The fsr reported that the logs showed the level sensor was not properly attached to the reservoir with many decoupling events which was later confirmed by the end user.The logs also showed high cpg pressure and some spikes in pressure throughout the case.The end user confirmed there was over pressure on the cpg line at one point.The level sensors and pressure module operated within manufacturer's specifications.Per data log analysis, on 12-feb-2020 a total of 15 over pressure alerts occurred on cpg pres and 1 pressure alert on arterial pressure.Both pressure transducers were properly calibrated (zeroed).There is no way to tell from the log if sufficient pressure was actually present to cause the alerts.It appears the pressure module is working properly and there may be an issue with the pressure transducer.This complaint is related to (b)(4) / medwatch #1828100-2020-00113.
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the pressure alert kept alarming.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the team stated that on (b)(6) 2020 during a cpb procedure they were hearing an audible level alert message, but that there was no messaging in the messaging area of the central control monitor (ccm) or the alarm/alert area of the secondary screen.They also stated that the level sensor pad was not properly attached to their rounded medtronic reservoir.The log data confirms that a level sensor error occurred.This did not delay the continuation of the surgical procedure.There was no harm or blood loss associated with the event.The case continued without issue.Noted is that there was a high pressure alert - due to spikes in the cardioplegia (cpg) line, can happen in normal procedure.
Additional Manufacturer Narrative
The reported complaint was 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: 9793348
• Report Number: 1828100-2020-00114
• Device Sequence Number: 2411466
• Product Code: DTQ
• UDI-Device Identifier: 00886799000724
• UDI-Public: (01)00886799000724(11)191122
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 802112
• Device Catalogue Number: 802112
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC RESERVOIR