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

Model Number 816300

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

H3: 81 - evaluation is in progress, but not yet concluded.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the central control monitor (ccm) displayed a 'system computer needs service' 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.

Manufacturer Narrative

During laboratory evaluation, the product surveillance technician (pst) connected the central control monitor (ccm) to lab use only (luo) testing equipment.The monitor booted up successfully with no apparent issues.The screens loaded with no problems and the touch screen functioned as expected.No error messages were observed and no events were indicated in the log.The unit operated as intended.

Manufacturer Narrative

The service repair technician (srt) could not duplicate the reported complaint.The srt replaced the peripheral component interconnect (pci) bus cable as a possible cause of the reported complaint and 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
• Type of Device: 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: 18184331
• MDR Text Key: 328696525
• Report Number: 1828100-2023-00355
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001325
• UDI-Public: (01)00886799001325(11)200805
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

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
• Device Operator: Health Professional
• Device Model Number: 816300
• Device Catalogue Number: 816300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 12/14/2023; 02/07/2024
• Supplement Dates FDA Received: 12/22/2023; 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1