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

Model Number	802111
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the manufacturer's sales associate, the level system was green indicating ready for use prior to going on bypass.After the level sensor displayed the 'level sensor unattached' message, the user facility removed the level sensor probe and added gel to make a better connection but the issue remained.The level module was replaced with one from another heart lung machine (hlm) and then a question mark displayed showing unassigned.The level system was turned off and the case was completed with no issues.After the case was completed another level sensor pad was added.The pad sat for 2-3 minutes and the probe was reinserted with the same issue.The field service representative (fsr) was unable to duplicate the reported complaint.He preformed testing on the level module and the sensors with passing results.The unit operated to the manufacturer's specifications.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the level module light emitting diode (led) flashed yellow and the unit displayed a 'level sensor unattached' message.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Corrected blocks: b5 and d10.Updated block: h6.The reported complaint was confirmed.Per data log review, on (b)(4) 2021 the level log shows many level alarm probe status changes from coupled to disconnected to coupled.This will cause a level disconnected alert (yellow) as reported.The log confirms the complaint.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Event or Problem Description
Corrected information that the reported complaint occurred prior to use of the device for a cardiopulmonary bypass (cpb) procedure.

• 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: 12358109
• Report Number: 1828100-2021-00300
• Device Sequence Number: 14421433
• Product Code: DTQ
• UDI-Device Identifier: 00886799000717
• UDI-Public: (01)00886799000717(11)210217
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 802111
• Device Catalogue Number: 802111
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 10/01/2021
• 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: RESERVOIR