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	10/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) replaced the flow module and the flow sensor.Testing was completed.The unit operated to the manufacturer's specifications.The flow sensor that was replaced was part number 6382, serial number (b)(4), udi (b)(4).The suspect devices were returned 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 unit had no flow reading while prime was flowing at five liters per minute (lpm).As mitigation the perfusionist reset power to the flow module and the flow readings were restored.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated block: h6.The reported complaint was confirmed.Per supplier evaluation, the failure was repeatable when the operational environment temperature was at 45 degrees celsius (c).The problem was not reproducible under normal room environment conditions.The solder joints exhibited wetting to the printed-board solderland and the component termination.The solder joint fillets had the correct wetting angle and were acceptable.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) connected the flow sensor and the flow module to lab use only (luo) testing equipment.Upon power up of the luo roller pump a 'flow: check sensor' message was displayed.The flow sensor was disconnected and a luo flow sensor was installed with the same message of 'flow: check sensor' displayed.The flow sensor was reinstalled and the flow module was disconnected.The pst installed a luo flow module and the system functioned as intended.It was determined that the flow module was defective.The module was disassembled and it was found that two chips on the printed circuit board had one leg each that had irregular soldering.

• 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: 12720453
• Report Number: 1828100-2021-00399
• Device Sequence Number: 11769270
• Product Code: DTQ
• UDI-Device Identifier: 00886799000687
• UDI-Public: (01)00886799000687(11)210826
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/03/2022

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: 802018
• Device Catalogue Number: 802018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 11/10/2021; 01/24/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 12/01/2021; 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• 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