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

Model Number 803480

Device Problem Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's clinical specialist visited on-site to address the issue the perfusionist was having with the occluder.It was found during this time that the issue was use related and no service was required by the field service representative (fsr).

Event Description

It was reported that the occluder was not calibrating.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The reported complaint was confirmed.Per the manufacturer's clinical specialist, the perfusionist noticed that the tubing was partially occluded in the occluder even though it was set at full open.He did not realize that this was normal, meaning that the tubing was slightly occluded even at full open in order to hold the tubing in place.The perfusionist decided to remove the tubing from the occluder head and felt that venous drainage improved which was communicated to the surgeon who then believed something was wrong with occluder.The clinical specialist re-explained the safety connections to the perfusion team as well as reviewed the operation, calibration, and use of the occluder.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

Additional information received that the issue happened during setup.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

• 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: 9712511
• MDR Text Key: 200041514
• Report Number: 1828100-2020-00058
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000779
• UDI-Public: (01)00886799000779(11)190722
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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: 803480
• Device Catalogue Number: 803480
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1