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

Model Number 149673

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

The reported issue was discovered during unit check-up.

Event Description

It was reported that during the use of the device for a non-clinical activity, the latch of the air bubble detector (abd) was broken.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.Per the perfusionist, the replacement latch was received.The damaged latch was changed out and discarded.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: 8084640
• MDR Text Key: 128055328
• Report Number: 1828100-2018-00598
• Device Sequence Number: 1
• Product Code: DTQ
• 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: 01/04/2019

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
• Device Operator: Health Professional
• Device Model Number: 149673
• Device Catalogue Number: 149673
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1