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 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per user, after they powered on the system, the cursor on the ccm did not move.Therefore, the clinical engineer had no choice but to force a shut-down.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the touch panel of the central control monitor (ccm) failed.As a result, they changed it with another ccm.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed that the touch screen had failed when attempting to move the cursor.The cursor¿s position would not move from the right edge of the screen.The pst determined that the customer¿s touch screen was the cause of the problem.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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: 6512033
• MDR Text Key: 73567267
• Report Number: 1828100-2017-00199
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151349
• 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
• Report Date: 06/15/2017

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: 05/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/24/2017; 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2009
• 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