| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00362-1 |
| Product Name/Description |
ME DPHC 0001 deltastream HC, 230V
(Cardiopulmonary bypass system heating/cooling unit)
All Serial Numbers affected
ARTG Number: 262576 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
There have been reported cases of nontuberculous endocarditis caused by mycobacteria or infections after cardiac surgery, in which hypothermia or hyperthermia devices were used. The manufacturer is updating the cleaning procedure of the device as a precautionary measure. Updated IFUs are expected to be available by the end of June 2016 |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The manufacturer is advising users to follow the following updated cleaning procedures:
· Clean the device every 14 days with Sanosil solution (3% H202). Since there may be an excess pressure during the cleaning process the tank lid must remain open during the cleaning process Furthermore, it is recommended that the water is changed daily and after each patient.
· Change least once a year, the hose assembly.
· All relevant hypothermia and hyperthermia devices should be operated in a separate room from the operating theatre. If this is not possible, another suitable measure should be found to ensure the risk of infection is effectively minimised. For example, by increasing the disinfection frequency of the surfaces of the devices and changing gloves after cleaning the equipment.
· Perform regular checks for contamination of equipment. The manufacturer recommends monthly intervals to determine the quality of the water.
This action has been closed out on the 07/12/2018. |
| Contact Information |
03 9775 1855 - Lovell Surgical Supplies International |