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 Calibration Problem (2890)

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

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) found that the epgs calibration button was greyed out upon arrival.After a minute, the calibration button started working, and the epgs passed calibration.The fsr restarted the heart lung machine (hlm) and a second epgs calibration was attempted.Upon starting the calibration, an alarm started to go off, and the light emitting diode (led) on the epgs began blinking red.The alarm was not identifiable as an error message did not display.The calibration said 'pass' however there was a red x above the gas and %oxygen (o2) icons, the alarm was still going off, and the epgs led was alternating between green and blinking red.After exiting the perfusion screen, the central control monitor (ccm) displayed a 'gas system 1: fail' message.The fsr replaced the egps, and release testing was performed.The unit operated to the manufacturer's specifications.

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the electronic patient gas system (epgs) lost gas flow and failed calibration.All connections were checked, and proper gas flow was verified, yet the epgs could not be recalibrated.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 analysis, the product surveillance technician (pst) connected the electronic patient gas system (epgs) to lab use only (luo) testing equipment.The pst did not observe any visual issues.The data log indicated several instances of a '5-volt (v) supply voltage test failure'.The supply voltage reaches the epgs via the cable, network interface card (nic) panel and power manager.The epgs and cable were available for evaluation.With the cable supplied with the epgs, the system was successfully calibrated, and held steady flow rates and fraction of inspired oxygen (fio2) blends throughout their respective ranges.It was determined that the epgs and cable 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 eletronic patient gas system (epgs) during cardiopulmonary bypass whereby the gas system lost gas flow and showed failed calibration and was unable to recalibrate.The product was changed out, with no delay and no blood loss, and the procedure was completed successfully.

Manufacturer Narrative

The reported complaint was confirmed.Per the service repair technician, the epgs was calibrated successfully and functioned as normal.As a preventative measure, the oxygen sensor was replaced.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: 18149599
• MDR Text Key: 328506873
• Report Number: 1828100-2023-00349
• 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: 02/02/2024

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
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 11/16/2023; 01/22/2024
• Supplement Dates FDA Received: 12/07/2023; 02/02/2024
• 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