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

Model Number	6382
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The field service representative (fsr) reported that during preventative maintenance (pm) of the device, the central control monitor (ccm) displayed a 'back flow' message when the centrifugal drive motor was idle.There was no patient involvement.
Additional Manufacturer Narrative
The fsr replaced the flow sensor and performed release testing.The unit operated to the manufacturer's specifications.
Additional Manufacturer Narrative
The reported complaint was confirmed.During laboratory evaluation, the product surveillance technician (pst) connected the flow sensor to lab use only (luo) testing equipment.While the pump was stopped, and no fluid was flowing through the circuit, the sensor reported a negative flow value (backflow).The sensor was disconnected so the pump could start, then reconnected while the pump was operating.After doing this, the sensor read a flow rate less than that of the calculated value on the pump display.The pst installed a luo flow sensor, and it functioned as intended.It was determined that the flow sensor did not operate as intended.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: 19794134
• Report Number: 1828100-2024-00191
• Device Sequence Number: 4134437
• Product Code: DTQ
• UDI-Device Identifier: 00886799000083
• UDI-Public: (01)00886799000083(11)221013
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2024

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: Other
• Device Model Number: 6382
• Device Catalogue Number: 6382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 08/13/2024; 09/24/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/03/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2022
• 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