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

Model Number 816300

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned to the manufacturer for further evaluation.(b)(4).

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure (cpb), the central control monitor (ccm) unexpectedly shut down.The user attempted a reboot and a message "computer needs service" was displayed on the monitor.The product was changed out after the procedure.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: during cpb, the ccm shut down.There were no error codes or indication of an issue prior to the shutdown.The pumps continued to work, as did other devices that allowed for manual control.Thus, cpb was able to be maintained.The user elected to re-boot the system-1 during cpb and this would temporarily stop all of the pumps.When the system was re-booted, the pumps would have been able to be re-started in about 10-15 seconds.When the ccm finally attempted to come on-line, the message "system computer needs service" was posted on the ccm and no ccm functions were able to be used.This results in the inability to select a perfusion screen, and none of the safety systems (air, pressure, and level) would have been able to be activated.This would allow manual operation of the pumps to complete the procedure, but no safety functions or connections would be active.The ccm was changed out after the procedure was completed.The case was completed successfully, without associated blood loss.Even though the system was re-booted with short loss of pumping capacity, the actual surgical procedure was not delayed.There was no harm observed.

Manufacturer Narrative

Investigation results: this issue could not be duplicated at subsidiary facility, however during lab evaluation the issue was duplicated.The single board computer (sbc) printed circuit board assembly (pcba) was the cause of the problem.The ccm started the boot up process then stopped near completion and displayed "system computer needs service" error message.When the pci1 connector on the sbc pcba was agitated, the ccm shut down and rebooted.Replacing the sbc pcba with a known good sbc pcba resolved the issue.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 SYSTEM CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6120634
• MDR Text Key: 60937236
• Report Number: 1828100-2016-00753
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2016

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: 11/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-10/14/11-020-C
• Patient Sequence Number: 1
• Treatment: APS 1 HEAT LUNG MACHINE