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

Model Number 816570

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 11/16/2023

Event Type  malfunction  

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the cardioplegia roller pump screen went blank.The controls on the central control monitor (ccm) were used for the roller pump until the screen came back on.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The field service representative (fsr) replaced the roller pump display and performed verification/release testing.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) connected the roller pump display to lab use only (luo) testing equipment.The screen was left on for two hours with no disruptions.The roller pump subassembly remained consistently illuminated throughout the evaluation and there were no signed of component failure.It was determined that the roller pump display met specification.

Event Description

Per clinical review: on (b)(6) 2023, the team at the user facility experienced a problem with the heart lung machine (hlm) while on cardiopulmonary bypass whereby the screen went blank on a small four-inch roller pump and the screen controls were used until the screen came back on.Therefore, there was no change out, no delay, no blood loss, and the procedure was completed successfully.

Manufacturer Narrative

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
• 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: 18284361
• MDR Text Key: 329956447
• Report Number: 1828100-2023-00367
• Device Sequence Number: 1
• Product Code: DTQ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2024

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: 816570
• Device Catalogue Number: 816570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 12/19/2023; 01/30/2024
• Supplement Dates FDA Received: 01/10/2024; 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• 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