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 Consequences Or Impact To Patient (2199)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.Additional information was received on this complaint during the clinical review that deemed this issue reportable.Per data log analysis, on (b)(6) 2018 at 15:06 the gas system reported "o2 sensor lifetime expired" which will cause the service gas system message reported.This indicates the oxygen (o2)% hours are greater than 100,000.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the electronic patient gas system (epgs) caused a "service gas system" message to be displayed on the central control monitor (ccm).The epgs was changed out for a external pole mounted gas blender.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the epgs was calibrated without issue for a cpb procedure on (b)(6) 2018.During the procedure the team received a service gas system in the message area of the ccm.The perfusionists were not confident that the epgs system was working to specifications, even though they did state that their patient's partial pressure of oxygen (po2) and partial pressure of carbon dioxide (pco2) were as expected and within hospital expected norms.The perfusionist opted to change their oxygen blending gas source to a stand alone sechrist gas blender and the case proceeded without issue for the remainder of the time on the heart-lung machine (hlm).The incident did not delay the surgical procedure.There was no blood loss or harm associated with the occurrence.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the "service oxygen (o2) sensor" and "service gas system" messages displayed on the central control monitor (ccm) when the electronic patient gas system (epgs) was connected to the system 1 simulator.The o2 percentage hours were found to be above 100,000 hours.The o2 percent hours were reset to zero and the epgs passed calibration with no errors.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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
• MDR Report Key: 8187592
• MDR Text Key: 131927396
• Report Number: 1828100-2018-00662
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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: 11/26/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MECHANICAL GAS FLOW METER; OXYGENATOR; SECHRIST GAS BLENDER
• Patient Outcome(s): Required Intervention