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

Model Number 816300

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the central control monitor ccm had a problem with the touchscreen cursor.After turning on the unit and the main menu appears, the arrow cursor is always on the right side and along the edge of the screen.The perfusionist can't enter the perfusion screen or service mode and even tried to shutdown the unit.As a result an alternate device was employed.This did delay the case less than a half and hour.The surgical procedure was completed successfully, with no blood loss, nor adverse consequences to the patient.The perfusionist reported this now occurs every time they turn on the unit.

Event Description

According to the manufacturer's subsidiary service engineer, during set-up of the central control monitor (ccm) the curser arrow was stuck along the right side and edge of the touch screen.This delayed the set-up of the device by less than 30 minutes, but did not delay the actual scheduled surgical procedure.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

The manufacturer's subsidiary service technician tried to calibrate the touchscreen using the universal serial bus (usb) cable adapter and computer mouse.Upon checking the unit, an error message "disk boot failure" appeared during self-test, they tried to clean the configuration card, reinserted it, attached keyboard and pressed enter, but the error is still present.He checked battery voltage (2.8 volts) and entered the bios setup and loaded the optimized defaults, but the error remained.Manufacturer's technical support advised the service technician that he needed to reset the central control monitor (ccm) back to its default settings.The battery needs to be replaced, as the voltage is too low.Technical support offered instruction on how to replace the battery and on how to reset the ccm to default settings.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

The reported complaint was not confirmed.Diligence attempts for part return were unsuccessful.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: TERUMO 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: 6005393
• MDR Text Key: 57164899
• Report Number: 1828100-2016-00666
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: RP
• 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,Followup,Followup
• Report Date: 07/10/2017

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/16/2017
• Supplement Dates FDA Received: 11/04/2016; 12/19/2016; 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1