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

Model Number 801764

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

The reported issues was discovered during training by the user facility.Per the manufacturer's subsidiary, the user facility's service technician found that all pumps worked as intended when attached to the left side of the pump, and only one pump worked on the right side.After attaching any second module, all modules attached to the right side went down.He reassembled the network interface card (nic) board of the right side and the unit worked as intended.

Event Description

It was reported that during the use of the device for a non-clinical activity, there were question marks and cross marks on the pump and module on the central control monitor (ccm).There was no patient involvement.

Manufacturer Narrative

Per the manufacturer's subsidiary, the user facility had recently replaced the batteries on the unit and knocked the power cable to network interface card (nic) board loose.After reassembling the unit the issue was resolved.

Manufacturer Narrative

The reported complaint was confirmed.Per data log analysis, on (b)(6) 2018, the central control monitor (ccm) is intermittently sending specific reset request to several modules: air bubble detector, occluder, temperature, level, pressure, large roller pump.Only one of the modules logs (temperature) covered that date and it was reporting ¿5v supply voltage test failure¿ events.This will then cause the red ¿x¿ and possible a ¿?¿ as reported.Most likely all of the listed modules were reporting the 5v error.If all were connected to the same network interface card (nic) the possible causes are the power manager, the nic, or the power cable that connects the power manager to nic.The cable connection is the most likely cause.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: 7678035
• MDR Text Key: 113756694
• Report Number: 1828100-2018-00365
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 0088679900063
• UDI-Public: (01)0088679900063(11)171114
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2018

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: 801764
• Device Catalogue Number: 801764
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 07/28/2018; 09/07/2018
• Supplement Dates FDA Received: 08/17/2018; 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1