| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00724-1 |
| Product Name/Description |
Organ Care System (OCS) Heart system - OCS Heart Console
OSC Heart Console Reference Number: 1200
Serial Numbers: 2486-1-15132, 2486-1-15129, 4929-4-15182
ARTG Number: 146269 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified a potential issue with the OCS Heart device that could affect proper operation. In particular, the blood warmer may heat beyond the set limit if the Heart Perfusion Module (HPM) is not installed in the OCS Console prior to taking the system out of Standby mode. Use of the OCS Heart device to support an organ at an elevated temperature may result in organ damage and/or turndown of organ for transplantation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
TransMedics will be correcting this issue through an update to the software and Instructions For Use (IFU). In the interim, users are to follow the directions in the Product Information Bulletin provided with the customer letter. The Bulletin describes the recommended sequence for installing the HPM into the OSC Console. In order to ensure proper performance, such as maintaining the configured blood temperature, users are to include the HPM in the system’s Self-Test by installing the HPM in the OCS Heart Console while the system is in Standby Mode.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9629 7455 - TransMedics |