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

Model Number	801041
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) had placed an order for a replacement.
Event or Problem Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the local display on the roller pump was broken/blank.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
Evaluation is in progress, but not yet concluded.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) observed a blank screen and intermittently missing graphics.He removed the customer's graphics driver board and placed it into the lab use only pump.The pump was powered on and characters were not generating properly determining that the customer graphics driver board is defective.The product was 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
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8868640
• Report Number: 1828100-2019-00417
• Device Sequence Number: 525406
• Product Code: DTQ
• UDI-Device Identifier: 00886799000540
• UDI-Public: (01)00886799000540(11)040213
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K163531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/03/2019

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
• Operator of Device: Health Professional
• Device Model Number: 801041
• Device Catalogue Number: 801041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 08/13/2019; 09/05/2019; 10/11/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 09/03/2019; 09/25/2019; 11/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1828100-06/05/2007-011-C
• Patient Sequence Number: 1