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

Model Number	195274
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the level detector was unable to be turned on via the central control monitor (ccm).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
Per the field service representative (fsr), she confirmed the level sensing system was unable to be turned on from the ccm.The level sensors were replaced.The unit operated to the manufacturer's specifications.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) connected the red level sensor to lab use only (luo) testing equipment.The level sensor detected the liquid when mounted on either side.Flexing the cable at either end did not produce any disruptions.The reservoir simulator was tilted, which caused the level sensor alert condition to be displayed on the screen as expected.The system recognized when the sensor was not attached, and it recognized when the sensor was disconnected from the module.No alerts occurred unless they were expected based upon conditions intentionally set during the evaluation.It was determined that the red level sensor met specifications.
Additional Manufacturer Narrative
Updated block: h6 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 17649581
• Report Number: 1828100-2023-00260
• Device Sequence Number: 20447346
• Product Code: DTQ
• UDI-Device Identifier: 00886799000496
• UDI-Public: (01)00886799000496(11)181031
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 10/12/2023

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: 195274
• Device Catalogue Number: 195274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 08/29/2023; 10/11/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 09/21/2023; 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2018
• 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