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

Model Number 816300

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) verified the reported issue.The ccm was replaced.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 the use of the device for a non-clinical activity, the central control monitor (ccm) had no display.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory evaluation, the product surveillance technician (pst) observed no display when power was applied to the central control monitor (ccm).It was determined that the power to liquid crystal display (lcd) backlight cable was the cause of the problem.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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: 8078418
• MDR Text Key: 128052764
• Report Number: 1828100-2018-00592
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001325
• UDI-Public: (01)00886799001325(11)130806
• 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
• Report Date: 12/19/2018

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: 816300
• Device Catalogue Number: 816300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 12/17/2018
• Supplement Dates FDA Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1