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 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) replaced the oxygen (o2) sensor.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the electronic patient gas system (epgs) displayed a 'service gas system message' error message.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Event Description

Per clinical review: during a bypass procedure on (b)(6) 2018, the perfusionist received a 'service gas system' message on the messaging bar of the heart lung machine (hlm).The team just continued the procedure with the equipment and had no concern with the sweep gas flow nor the percentage of fraction of inspired oxygen (fio2) being delivered to the patient.After the procedure, the field service representative (fsr) did come in and replace the oxygen (o2) sensor.This perfusion group does leave their hlms plugged into the main power and powered on at all times.The incident did not delay the surgical procedure and there was no harm or blood loss associated with the occurrence.

Manufacturer Narrative

Please disregard previously reported information as this complaint has been determined to be not mdr reportable.The device met specification and performed as intended, therefore did not malfunction.

• 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: 7628859
• MDR Text Key: 112003844
• Report Number: 1828100-2018-00325
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)120905
• 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: 09/19/2018

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 07/12/2018; 09/19/2018
• Supplement Dates FDA Received: 08/06/2018; 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1