MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. 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 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the screen of central control monitor (ccm) was frozen and did not respond when touched.As a result, the unit was removed from service and replaced with a back up unit.The surgical procedure was completed successfully.There was an initial delay of 20 minutes.There was no blood loss, nor adverse consequences to the patient.Per clinical review: the field service representative (fsr) visited the facility and was able to gather information related to the events of the incident.During set-up and preparation of the perfusion circuit prior to cardiopulmonary bypass, the perfusionist was not able to open a perfusion screen.The perfusion tab on the main screen was not responding to touch.The perfusionist re-booted 3 times, but the issue remained and the perfusionist was not able to open a perfusion screen.The perfusionist elected to bring in another perfusion system (including the heart-lung machine) and this delayed the start of the procedure by about 20 minutes.The patient was not brought to the operating room until the new system was in the room and set-up and priming had progressed to an acceptable level.The local fsr inspected the ccm a few days later and he noticed a "dent" in the middle of the ccm and this would impact the ability to use the screen as the ccm is a single-point control device.There is a caution in the operator's manual that informs the user to ensure there is no additional contact with the touch screen during operation as unintended input may result.The case was completed successfully, with a 20 minute initial delay.There was no associated blood loss and no harm was observed.

Manufacturer Narrative

The field service representative (fsr) found that the screen was not functioning on the central control monitor (ccm) and could not make any selections.Fsr replaced ccm with loaner and was sent to service for repair.The unit operated to the manufacturer¿s specifications.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed that the central control monitor (ccm) had stable operation with no freezing.Per data log analysis: the complaint indicates the issue occurred on (b)(6) 2017, but there are no log entries on that date.The system was used on (b)(6) 2017 and may have had issues.On (b)(6) 2017: 06:27:29 system powered up.06:34:59 logging stops without any indication of a screen touch (possible screen freeze).06:36:47 system powered up again.06:42:42 logging stops without any indication of a screen touch (possible screen freeze).07:07:33 system powered up again.07:53:33 logging stops without any indication of a screen touch (possible screen freeze).13:49:51 system powered up again.13:50:10 a perfusion screen is opened (touchscreen is working).13:50:57 perfusion screen is exited (touchscreen is still working).13:52:03 logging stops.14:32:42 system powered up.14:32:45 logging stops and the system is not powered up anymore on that date.Next power up is on (b)(6) 2017 and the touchscreen is working.Each time logging stops is a possible indication of a touchscreen freeze.It's likely only the touchscreen froze and the ccm was still running.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician (srt) could not duplicate the reported complaint, but replaced the single board computer (sbc) board and printed circuit interface (pci) bus interface cable as a precaution.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 CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6503068
• MDR Text Key: 73335154
• Report Number: 1828100-2017-00190
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/29/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: Not provided; 07/14/2017; 08/14/2017; 09/21/2017
• Supplement Dates FDA Received: 06/02/2017; 08/08/2017; 09/05/2017; 09/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2010
• 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