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	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the centrifugal drive motor had an 'overspeed' alarm.The surgical procedure was completed successfully.There was delay, no blood loss, nor adverse consequences to the patient.Per clinical review: on (b)(6) 2022, the team experienced a problem with their heart lung machine (hlm) while on cpb, whereby the centrifugal pump alarmed 'overspeed' and stopped functioning.The unit was changed out and the surgery was completed successfully, with no delay and no blood loss.The perfusionist reported having trouble maintaining desired flow on the centrifugal control unit (ccu), eventually reaching maximum revolutions per minute (rpms).It then alarmed 'overspeed' and stopped.He then hand-cranked until the centrifugal head could be moved to a medtronic 560 and finished the case successfully (they used a medtronic centrifugal head with an adaptor on the manufacturer motor drive).
Additional Manufacturer Narrative
The field service representative (fsr) found the drive motor to not run and an 'overspeed' alarm to display immediately.The fsr also spoke with the manufacturer's technical support specialist with regards to the logs and it was confirmed that there was a speed sensor failure.The fsr installed a new drive motor.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) connected the centrifugal drive motor to lab use only (luo) testing equipment.There was no observation of an 'overspeed' alarm while the water loop speed increased from 1500 revolutions per minute (rpm) to 3600 rpm.He did end up observing a 'service pump' message and noted the same 'speed sensor disconnected/broken' events in the logs.The pump was opened and inspected for any defects and no visible defects or damaged wires were observed.It was determined the motor did not meet specification.Per data log review: based on the centrifugal control unit (ccu), there were multiple speed sensor disconnected/broken errors.The pump displayed an 'overspeed' message and the ccu log showed a speed sensor disconnected/broken error.(b)(6) 2022 14:56:57 internal trigger deactivated speed sensor disconnected/broken (6); (b)(6) 2022 14:56:57 pump control state change stopped (0), (b)(6) 2022 14:56:57 internal trigger activated speed sensor disconnected/broken (6) (b)(6) 2022 14:56:57 speed sensor error invalid format for event id 16026 (1), (b)(6) 2022 14:56:56 pump control state change started (1), (b)(6) 2022 14:56:26 pump control state change stopped (0), (b)(6) 2022 14:56:06 pump control state change started (1), (b)(6) 2022 14:56:01 internal trigger deactivated speed sensor disconnected/broken (6) (b)(6) 2022 14:56:01 pump control state change stopped (0).
Additional Manufacturer Narrative
Updated block:h6 the reported complaint was 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 13732134
• Report Number: 1828100-2022-00103
• Device Sequence Number: 4806664
• Product Code: DTQ
• UDI-Device Identifier: 00886799000458
• UDI-Public: (01)00886799000458(11)171017
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/19/2022

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: 02/22/2022
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 03/17/2022; 04/25/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 04/08/2022; 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2017
• 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 TUBING PACK AND 560
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown