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

Model Number	802110
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) could not duplicate the reported complaint.The logs showed that there was a low voltage supply to the abd module.The fsr replaced the abd module.The unit operated to the manufacturer's specifications.The suspect part will be sent back to the manufacturer for further evaluation.
Event or Problem Description
It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, the air bubble detector (abd) module light emitting diode (led) flashed orange and red and the perfusion screen intermittently displayed a question mark over the abd icon.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
During laboratory analysis, the product surveillance technician (pst) connected the air bubble detector (abd) module to lab use only (luo) testing equipment.The air bubble sensor tubing was filled with 60% water and 40% air.The abd module was monitored for four hours with no observations of any intermittent '?' marks, flashing orange or red lights and passed all testing.The pst conducted an microscopic examination with no observation of any anomalies.The abd module met specification.
Additional Manufacturer Narrative
Updated block: d9.
Additional Manufacturer Narrative
The reported complaint was confirmed.Per data log review: the log showed that the air bubble detector (abd) module was repeatedly getting an 'entering broken mode 56' error which is a controller area network (can) test failure.This causes the module to reboot which will cause the abd light emitting diode (led) to flash green, yellow, and red as reported.The log confirms the complaint.On (b)(6) 2021 the problem no longer occurred.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: 12791302
• Report Number: 1828100-2021-00416
• Device Sequence Number: 5588561
• Product Code: DTQ
• UDI-Device Identifier: 00886799000700
• UDI-Public: (01)00886799000700(11)210106
• 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,Followup,Followup
• Report Date (Section B): 01/27/2022

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: 802110
• Device Catalogue Number: 802110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• 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: 10/19/2021
• Supplement Date Received by Manufacturer: 11/11/2021; 12/08/2021; 01/10/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 12/06/2021; 12/22/2021; 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2021
• 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