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 Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) was unable to duplicate the reported complaint.He replaced the electronic patient gas system (epgs) as a precaution.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.Data logs were returned to the manufacturer on 1-may-2018.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, a "gas module failure" error message was displayed.The system was rebooted.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed the service repair technician (srt) was unable to duplicate the reported complaint.He replaced the electronic patient gas system (epgs) pod assembly as a precaution.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.

Manufacturer Narrative

Further information was received that the manufacturer was aware of the reported complaint on 25-apr-2018.Per data log analysis, on (b)(6) 2018 the system is powered up at 6:26:22 am.The central control monitor (ccm) sends a "spec reset req" which indicates a module powered up with a bad operational status (possible "0c", normally "00").A perfusion screen is opened and the ccm attempts to put the gas system online but the gas system does not respond.This indicates the gas system is the module with a bad operational status.This would have caused a red 'x' to be placed on the gas system icon as reported.At 6:31:21 am the perfusion screen is exited and the system is power cycled.When the system is powered back on the gas system comes up normally.The log indicates the gas system failed self test on the first power up, likely a 0c operational status.This was corrected by power cycling the system.Most likely the generic board is the cause for the self test failure which is part of the gas system pod.During laboratory analysis, the product surveillance technician (pst) observed the electronic patient gas system (epgs) to function as intended.

• 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: 7526389
• MDR Text Key: 108735311
• Report Number: 1828100-2018-00267
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)051205
• Combination Product (y/n): N
• PMA/PMN Number: K153376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2018

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: 05/07/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 05/17/2018; 06/28/2018
• Supplement Dates FDA Received: 06/11/2018; 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1