MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 802018

Device Problems Sensing Intermittently (1558); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the manufacturer's clinical specialist, the flow reading was displayed on the central control monitor (ccm) and the local display when suddenly dashes were displayed appeared instead of the flow reading.While checking the connections the flow was displayed again.The flow module was placed under the splash panel and when he went to put the splash panel back on, the flow reading went back to dashes.He changed the position of the cables to the other network interface card (nic) and the flow immediately came back on.When the splash panel was put back on the flow went back to dashes.He was able to get the flow readings displayed when he left the displaced connect off.A few minutes later, without any manipulation, the flow reading was back to dashes.The flow sensor was located post arterial filter.The field service representative (fsr) verified the flow module did not show flow, only dashes.He replaced the flow module.The unit operated to the manufacturer¿s specifications.The suspect device was returned to the manufacturer for further evaluation.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the flow reading disappeared and was replaced by dashes.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

(b)(4).During laboratory analysis, the product surveillance technician (pst) connected the device under test (dut) to the system 1 simulator using lab peripherals to construct a basic centrifugal water loop with flow sensor on 3/8¿ tubing.The pst powered on the test setup, opened perfusion window and assigned the dut flow module.Proper flow immediately observed on the central control monitor (ccm) and pump controller display.The pst gradually warmed the outside of the dut flow module using a heat gun while observing the internal reported temperature within the ¿module info¿ tab.Beginning at approximately 45 degrees celsius (c), the temperature was raised to 46.4c before the flow displays reflected three dashes (¿---¿) which indicates loss of flow data, which duplicated the reported complaint.The environmental operating temperature specification upper limit is 40°c (room ambient).The ccm status bar at the top of the perfusion screen also displays ¿flow: check sensor¿ when it fails.The cause of failure is the flow module application board.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 reported complaint was confirmed.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 Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7125551
• MDR Text Key: 95457466
• Report Number: 1828100-2017-00571
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 802018
• Device Catalogue Number: 802018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1828100-01/09/18-001-C
• Patient Sequence Number: 1