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

Model Number 801188

Device Problem Output Problem (3005)

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the central control monitor (ccm) displayed a 'high air supply pressure' message after extracorporeal circulation.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Event Description

Per clinical review: the user reported an issue with the heart lung machine (hlm) during cardiopulmonary bypass (cpb), also reported as after coming off cpb.In either case, the user reported seeing a 'high air supply pressure' message appear on the central control monitor (ccm).There was no reported delay to the procedure and the surgery was completed successfully with no patient harm or blood loss.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) connected the electronic patient gas system (epgs) to lab use only (luo) testing equipment.He observed instances of 'oxygen (o2) pressure high' in the log data.The pst observed that when he increased the o2 pressure to around 70 pounds per square inch (psi), a high o2 pressure alert would occur which is the expected result of the system.It was determined that the system operated as intended.The service repair technician (srt) could no longer repair the unit as it was end of service life (eosl).

• 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: 18259684
• MDR Text Key: 329805495
• Report Number: 1828100-2023-00363
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2024

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: 801188
• Device Catalogue Number: 801188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/04/2023
• Supplement Dates Manufacturer Received: 11/29/2023; 01/11/2024
• Supplement Dates FDA Received: 12/21/2023; 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2008
• 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