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	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) verified the reported complaint.The light emitting diode (led) on the module did not come on.The fsr replaced the assembly flow module.The unit operated to the manufacturer's specifications.
Event or Problem Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the central control monitor (ccm) displayed a 'service module art flow' message.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
Updated block: h6 the reported complaint was confirmed.Per supplier evaluation, the five volt (v) and ground were shorted.This was confirmed with a digital voltmeter.After removing components one by one it was found that the integrated circuit at the u11 position had failed causing the short.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
Updated blocks: d9 and h6.During laboratory analysis, the product surveillance technician (pst) installed the flow module into lab use only (luo) testing equipment.Upon powering on the unit, the light emitting diode (led) did not power on and the central control monitor (ccm) displayed a 'flow1: service module' message.The pst replaced the printed circuit board assembly (pcba) from the module with a luo pcba.The module then functioned as intended determining that the pcba of the module was defective.Upon microscopic evaluation of the pcba, he had found that the electrical component u1 was damaged and failed.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
Per data log review: on (b)(6) 2022 the flow meter reported several errors.5.0 volt (v) supply range status event (8) 7.5v supply range status event (8) motor voltage (vmot) power state change (disabled) vmot over-current alarm (710) pod initialization failure - erasable electronically programmable read only memory (eeprom) checksum invalid this would have caused the message 'art flow: service module' as reported.Subsequent power ups caused the pod initialization failure - eeprom checksum invalid each time.The log confirms the complaint.

• 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: 15451127
• Report Number: 1828100-2022-00334
• Device Sequence Number: 5835904
• Product Code: DTQ
• UDI-Device Identifier: 00886799000687
• UDI-Public: (01)00886799000687(11)220502
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/21/2022

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
• 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: 08/25/2022
• Supplement Date Received by Manufacturer: 09/19/2022; 10/11/2022; 12/21/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 10/06/2022; 11/01/2022; 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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