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 12/06/2023

Event Type  malfunction  

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood had turned black within two minutes.As a result, the oxygen (o2) source was switched to an oxygen tank.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) could not duplicate the reported complaint.The logs were also reviewed, and no issues were found.As a precaution the electronic patient gas system (epgs) was replaced.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) connected the electronic patient gas system (epgs) to lab use only (luo) testing equipment.The epgs calibrated successfully, and several setpoints for flow and fraction of inspired oxygen (fio2) were found to be steady and accurate.After reviewing log data on the date of the reported complaint, there did not appear to be any unusual events.The epgs operated as intended.

Event Description

Per clinical review: on (b)(6) 2023, the team at the user facility experienced a problem with the heart lung machine (hlm) electronic patient gas system (epgs) during cardiopulmonary bypass (cpb), whereby a few minutes after going on bypass, the 'blood turned black' and they switched to an oxygen tank and completed the case using the oxygen tank.The case was completed successfully with no harm to the patient, no delay, and no blood loss.

Manufacturer Narrative

The service repair technician (srt) was not able to duplicate the reported complaint.The epgs calibrated successfully and functioned as intended.The unit operated to the manufacturer's specifications.

• 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: 18366021
• MDR Text Key: 331072110
• Report Number: 1828100-2023-00379
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)220601
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• 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
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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
• Patient Outcome(s): Required Intervention