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

Model Number	164267
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) replaced the centrifugal drive motor.The unit operated to the manufacturer's specifications.The suspect device was sent back to the manufacturer for further evaluation.
Event or Problem Description
The field service representative (fsr) reported that during field service installation of the device, an overspeed message was observed on the pump display and the motor would not rotate.There was no patient involvement.
Additional Manufacturer Narrative
Updated block: d9.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) connected the centrifugal drive motor to lab use only (luo) testing equipment.The pst connected a water loop and set the revolutions per minute (rpm) to 1600 for 24 hours.There was no observation of an 'overspeed' message on the pump display.It was determined that the centrifugal drive motor met specification.
Additional Manufacturer Narrative
Updated block:h6 the reported complaint was confirmed.Per data log review: on (b)(6) 2021, the centrifugal pump was started and then stopped one second later with a 'speed sensor' error.This will cause the reported 'overspeed' message.The log confirms the complaint.The service repair technician (srt) could not duplicate the reported complaint.Release testing was performed.The unit operated to the manufacturer's specifications.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: 13046098
• Report Number: 1828100-2021-00479
• Device Sequence Number: 5436736
• Product Code: DTQ
• UDI-Device Identifier: 00886799000458
• UDI-Public: (01)00886799000458(11)211026
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/17/2022

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: Other
• Device Model Number: 164267
• Device Catalogue Number: 164267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• 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: 12/02/2021
• Supplement Date Received by Manufacturer: 12/28/2021; 01/20/2022; 03/09/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 01/18/2022; 02/10/2022; 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown