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	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) could not duplicate the reported complaint.The fsr replaced the level sensor module and both of the level sensors.Verification/release testing was preformed.The unit operated to the manufacturer's specifications.The yellow level sensor that was replaced: pn: 195215, sn: (b)(4), manufacturer date: 21-dec-2000.The red level sensor that was replaced: pn: 195274, sn: (b)(4), udi: (b)(4).The suspect parts were returned to the manufacturer for further evaluation.
Event or Problem Description
It was reported that prior to use of the device for a cardiopulmonary bypass (cpb) procedure, the level sensors were continuously alarming.As a mitigation, the level sensors were turned off.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) connected the level module and level sensors to lab use only (luo) testing equipment.The system was monitored for three hours and 12 minutes with no observations of the unit inadvertently alerting or alarming.It was determined that the level module and level sensors met specification.Per data log review: on (b)(6) 2021, the level log showed many alarm probe status changes from coupled to uncoupled to coupled.This will cause 'level not attached' alerts (not alarms), which is most likely what the end user was reporting.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.

• 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 12971310
• Report Number: 1828100-2021-00467
• Device Sequence Number: 19937514
• Product Code: DTQ
• UDI-Device Identifier: 00886799000717
• UDI-Public: (01)00886799000717(11)171201
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown