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 Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2018

Event Type  malfunction  

Event Description

After use of the device for a cardiopulmonary bypass (cpb) procedure, the user reported inaccurate oxygen readings on the electronic patient gas system (epgs).There were no reported adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed.Per data log analysis, on (b)(6) 2018 at 6:41:07 am, calibration is successfully performed and flow is set to 0 liters per minute (l/min).At 7:44:41 am flow is set to 1.91 l/min while fraction of inspired oxygen (fio2) is set to 75.1%.At 7:45:30 am the gas system reports "o2 sensor and blender disagree, blender = 75.2% and sensor = 20.2%.This error cleared at 7:46:26 am.There were many flow and fio2 changes after this with no more indication of a problem.The log shows the oxygen (o2) reading was incorrect for about one minute.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

The field service representative (fsr) was unable to verify the reported complaint.He checked all hose connections and the electronic patient gas system (epgs) operation.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
• MDR Report Key: 8094090
• MDR Text Key: 128055097
• Report Number: 1828100-2018-00600
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2019

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: 11/02/2018
• Initial Date FDA Received: 11/21/2018
• Supplement Dates Manufacturer Received: 11/30/2018; 01/18/2019
• Supplement Dates FDA Received: 12/16/2018; 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1