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

Model Number 801763

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) verified red x's on the icons connecting to the right side of the network interface card (nic) printed circuit board (pcb).The icons with red x's caused intermittent rebooting.He replaced the nic pcb but after 20 minutes of running the red x's reappeared.The nic cables were replaced resolving the problem.The unit operated to the manufacturer's specifications.The suspect parts were 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 unit was turning on and off.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.During laboratory analysis, the product surveillance technician (pst) was not able to duplicate the reported issue.As per pst, the ¿red x¿s¿ will appear within a perfusion screen for assigned devices (pumps or modules) that are recognized as being present but are giving a ¿broken mode¿ status to the nic communication channel.This can signify the loss of the five volts direct current (vdc) power to the device, or a severe drop in that voltage (to around 4.6 vdc or lower) to an individual device or to the entire network interface card (nic) panel.The bulk of this evaluation focuses on the assumption that a dip in five vdc power to the entire nic panel was occurring since several devices were involved, all on the right side nic panel.The pst inspected the returned cables and no damage or other anomalies were observed on any of the four returned cables.The power and can cables were manipulated while observing the perfusion display for red-x or other anomalies but no issues were observed.The device under testing (dut) with pumps and modules run for over 12 hours with no issue.Connected nic panel to a power manager board test fixture using the right side nic power and can communication cables and the device powered on properly with no issues.Per log analysis, on (b)(6) 2018, several of the pumps and modules are intermittently reporting "5v supply voltage test failure" and sometimes rebooting.Most likely the issue is with modules plugged into the right nic (nic3).The power manager is reporting nic brick #3 state changes to "connected with fault", likely from the reboots.Possible causes are the power manager, the power cable from the power manager to the right nic, or the nic itself.The cable connection is the most likely cause.These are the modules/pumps reporting 5v errors: large rollerlarge roller, large roller, gas system, flow meter, occluder, air bubble detector (abd).If additional information on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: ADVANCE 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: 7650457
• MDR Text Key: 112741511
• Report Number: 1828100-2018-00347
• 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
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-05/04/12-009-C
• Patient Sequence Number: 1