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

Model Number 816571

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was confirmed.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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 12719806
• MDR Text Key: 327283323
• Report Number: 1828100-2021-00395
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001370
• UDI-Public: (01)00886799001370(11)200316
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2020
• 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