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

Model Number 816300

Device Problem Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

Per the perfusionist, he noticed the date changed to the year 2074.The perfusionist changed the date back to the correct date.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the central control monitor (ccm) displayed a "you have exceeded two-year service life of your batteries" message.No other details regarding the nature of this event were provided.

Manufacturer Narrative

Corrected block: h6.Updated blocks: d10 and h3.H3: 81 evaluation is in progress, but not yet concluded.

Manufacturer Narrative

Per data log analysis, on (b)(6) 2019, the system is used and all is okay.The next power up, the central control monitor (ccm) changed the date to (b)(6)2074.This triggered the battery life expired message as reported.The system was left powered on until the date changes to (b)(6)2074.A perfusion screen was opened and the date was corrected to (b)(6) 2019 by the user.This corrected the issue causing the battery life expired message so the message no longer displayed.The only issue in the log was the ccm date change which did cause the battery life expired message to display until the date was corrected.

Event Description

Additional information was received that the product was changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Updated blocks: h3 and h6 the reported complaint was confirmed.The field service representative verified the date on the central control monitor (ccm) had changed to the year 2074 via the logs.He replaced the ccm.The unit operated to the manufacturer's specifications.During laboratory analysis, the product surveillance technician connected the ccm to the lab use only heart lung machine (hlm) and powered on.The date and time were verified on the system computer.The ccm was observed for 56 hours with no change in date or time.The product will be sent to service to ensure it meets the 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 CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 9477877
• MDR Text Key: 199113545
• Report Number: 1828100-2019-00663
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001325
• UDI-Public: (01)00886799001325(11)190118
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/24/2020

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: 03/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/21/2020; 03/24/2020; 04/21/2020
• Supplement Dates FDA Received: 02/12/2020; 04/14/2020; 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1