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

Model Number 801763

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

The reported issue was discovered when the unit was powered up for a battery check.The field service representative (fsr) verified the multiple red 'x's on the ccm.He installed a new network interface card (nic) board, but this did not resolve the issue.He then installed a new power manager board and this corrected the problem.The unit operated to the manufacturer's specifications.The suspect parts were sent back to the manufacturer for further evaluation.

Event Description

It was reported that during use of the device for a non-clinical activity, there were red 'x's appearing on the central control monitor (ccm).There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) was unable to duplicate the reported complaint.He did observe corrosion on f1, likely to have caused an intermittent connection between the five volt supply line and the right network interface card (nic) panel resulting in the reported complaint of the red x.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

Per data log analysis, most of the logs were flushed since the system was left on.Most events were from (b)(6) 2018.Many pumps/modules reporting five volts (v) supply voltage test failure and rebooting.The five v reported by the power manager was 5.16 v.This will cause the red x and ? on the pump/module icons.

• 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: 8178329
• MDR Text Key: 130774356
• Report Number: 1828100-2018-00651
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• 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: 12/17/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828200-03/27/2012-006-C
• Patient Sequence Number: 1