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

Model Number 802112

Device Problem Failure to Sense (1559)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per user facility, channel b of the device would zero but would not display the pressure.The pressure pod light emitting diode (led) was dark.The field service representative (fsr) sent the user facility a replacement pressure pod.The user facility installed the new pressure pod and the issue remained intermittently.The fsr verified with a pressure simulator that both channels a and b would zero and display simulated pressure inputs.He checked the pressure module in all slots of the network interface cable (nic) board but the problem could not be duplicated.He found the user facility had a faulty pump transducer interface cable.The cables were replaced.He tested the newly installed pressure pod on both channel a and b with the new cables and there were no issues.The unit operated to the manufacturer's specifications.The suspect device will be 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 pressure module stopped working and displayed a ? on the central control monitor (ccm).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

The reported complaint was confirmed.Per data log analysis, the issue occurred on (b)(6) 2017, but the date was not set correct in the central control monitor (ccm).The date in the ccm was (b)(6) 2017.The system log does not cover (b)(4) 2017.Per pressure log analysis, the log only contained events for part of (b)(4) 2017 because the channel 2 pressure sensor was logging many "connected/disconnected" events.Eventually this behavior stopped.The issue of no light emitting diode (led) was not in the log since the log only covered 67 minutes.Most likely the logging of the led off issue was lost due to the "connected/disconnected" events.During laboratory analysis, the product surveillance technician observed the pressure module to function normally during evaluation.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: 7095010
• MDR Text Key: 95078112
• Report Number: 1828100-2017-00549
• 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
• Report Date: 03/01/2018

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: 802112
• Device Catalogue Number: 802112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 12/07/2017; 02/28/2018
• Supplement Dates FDA Received: 12/22/2017; 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1