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 Codes	Decoupling (1145); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) connected the centrifugal drive motor to lab use only (luo) testing equipment.At low rpms, a light ticking sound was present.As the rpms increased, the noise was more noticeable but no disruption in function was observed.The pst disassembled the centrifugal drive motor and observed debris on the magnets on both portions of the motor.It was determined that the centrifugal drive motor did not meet specification.
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the centrifugal drive motor was noisy.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was a one-minute delay.There was no blood loss, nor adverse consequences to the patient.Per clinical review: the user reported an issue with their centrifugal pump drive motor during cpb.Specifically, they reported a noisy centrifugal drive motor.They noted that the noise was slightly louder when compared to another drive motor at their facility.The noise started after attaching the medtronic adapter plate on the manufacturer's centrifugal drive motor.The medtronic adapter plate was subsequently attached to a medtronic centrifugal pump disposable.The user described a loud shuddering noise but stated initially that there was not a loss of pump flow.Suddenly, they noted a loss of flow, which they attributed to a decoupling of the centrifugal pump to the disposable and adapter plate.When using an adapter plate, the decoupling can be between the adapter plate and the drive motor, or centrifugal pump disposable and the adapter plate.To mitigate the decoupling the user dropped the revolutions per minute (rpm) of the centrifugal pump to 0, which would allow recoupling of the centrifugal disposable/adapter plate or drive motor/adapter plate.This resulted in approximately a 10 second period of hypoperfusion for the patient.This maneuver temporarily mitigated the problem, but the shuddering began again, so the user decided to replace the adapter plate with another one.This resulted in another 10-20 second period of hypoperfusion for the patient.In total, there was an approximate one-minute delay to the procedure.The surgery was completed successfully, and there was no injury/blood loss reported.
Additional Manufacturer Narrative
The reported complaint was confirmed.Further laboratory evaluation was conducted by the product surveillance technician (pst).The pst attached an adapter onto the centrifugal motor to closely simulate the setup from the perfusionist team to see if that would affect the detachment of the motor.He ran the pump, and noticed there was additional noise due to the added moving parts from the adapter, but it was determined that the vibration was not enough to reasonably cause a detachment.The service repair technician (srt) replaced the centrifugal drive motor window.The unit operated to the manufacturer's specification.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: 16497558
• Report Number: 1828100-2023-00069
• Device Sequence Number: 6366473
• Product Code: DTQ
• UDI-Device Identifier: 00886799000458
• UDI-Public: (01)00886799000458(11)171024
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Report Date (Section B): 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 164267
• Device Catalogue Number: 164267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC ADAPTER PLATE.; MEDTRONIC CENTRIFUGAL PUMP DISPOSABLE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown