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

Model Number	802018
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
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 flow module did not display a flow rate reading and was only showing zeros.The flow module was disconnected, reconnected and the issue was resolved.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
The field service representative (fsr) verified the function of the flow module and the flow sensor.He confirmed that the flow rate was displayed on the central control monitor (ccm).The flow module and flow sensor were replaced.The unit operated to the manufacturer's specifications.
Additional Manufacturer Narrative
The udi information of the flow sensor that was replaced and returned along with the flow module was pn 6382, sn (b)(6) udi (b)(4).Per data log analysis, on 15-mar-2021: 05:56:46 perfusion screen was opened.08:51:26 backflow alarm (indicates flow is being measured).12:59:28 perfusion screen was exited.13:01:13 the system was powered up after a power down.13:02:01 perfusion screen was opened.13:11:22 perfusion screen was exited.Normally when a flow meter is not measuring flow, the flow is displayed as '---'.In this case it was reported that the flow was displayed as '000'.At 08:51:26 the flow meter reported a backflow alarm indicating flow was not '000'.In this case, the log cannot be used to confirm the complaint.During laboratory analysis, the product surveillance technician (pst) connected the flow module and flow sensor to a lab use only (luo) roller pump with tubing filled with water and ran the pump.The flow readings were as expected and the module and sensor both met specification.
Additional Manufacturer Narrative
The reported complaint could not be 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
• MDR Report Key: 11638306
• Report Number: 1828100-2021-00124
• Device Sequence Number: 3496095
• Product Code: DTQ
• UDI-Device Identifier: 00886799000687
• UDI-Public: (01)00886799000687(11)201012
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup,Followup
• Report Date (Section B): 08/19/2021

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: 802018
• Device Catalogue Number: 802018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/18/2021; 06/29/2021; 07/28/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 06/09/2021; 07/21/2021; 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1