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

Model Number 802100

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.The field service representative (fsr) was able to get the touch screen to work but it was intermittent.The fsr replaced the unit with another ccm and the suspect unit was returned to the manufacturer for further evaluation.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the touch screen of the central control monitor (ccm) was not working.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The product surveillance technician (pst) conducted an evaluation of the returned device, and the complaint was duplicated.The touch screen was not working at gouged areas.Exterior inspection revealed multiple gouges on touch screen.He connected the ccm to aps1 power supply and powered the device on.The pst attempted to move the cursor to different areas of touch screen.It was determined that the touch screen was the cause of the problem.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 CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6577952
• MDR Text Key: 75624552
• Report Number: 1828100-2017-00248
• 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
• Report Date: 06/09/2017

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: 802100
• Device Catalogue Number: 802100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/26/2017
• Initial Date FDA Received: 05/19/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2006
• 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