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	Failure to Power Up (1476); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) verified that the centrifugal control unit (ccu) would shut down.After consulting with the manufacturer's technical support specialist on the log data, he replaced the centrifugal motor.The unit operated to the manufacturer's specification.The centrifugal motor involved was part number: 816572, serial number: (b)(4), udi: (b)(4).
Event or Problem Description
After use of the device for a cardiopulmonary bypass (cpb) procedure , the user reported that the centrifugal control unit (ccu) gave an 'overspeed' alarm when barely moving the speed control knob, then it would not power up at all.There were no reported adverse consequences to the patient.
Additional Manufacturer Narrative
The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) started the centrifugal pump up and a 'stopped: overspeed' message appeared.When the pst opened the pump up, liquid dribbled out.The pst observed that the magnets and screws were thoroughly rusted and there were exposed wires and contacts.It was determined that the centrifugal motor did not meet 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: 14315453
• Report Number: 1828100-2022-00184
• Device Sequence Number: 20045398
• Product Code: DTQ
• UDI-Device Identifier: 00886799000458
• UDI-Public: (01)00886799000458(11)170727
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/10/2022

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: 164267
• Device Catalogue Number: 164267
• 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: 04/18/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2017
• 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
• Patient Sex: Unknown