| TGA Action ID |
RC-2024-RN-00987-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
MiniCap Extended Life PD Transfer Sets with Twist Clamps, Twist Clamp - Extra Short, Twist Clamp - Extra Long
Product Code: R5C4482, R5C4483, R5C4484
Multiple lot numbers and UDI's
ARTG 167416
(Vantive Pty Ltd - Tubing set, dialysis, peritoneal) |
| ARTG Number |
167416 |
| Action Type |
Product Defect Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Two problems have been identified with the MiniCap Extended Life PD Transfer Sets.
1. Separation of the female connector from the main body of the transfer set. Separation of the female connector from the main body of the transfer set would not directly lead to a breach in sterility of the fluid path. However, indirectly may increase the risk of peritonitis.
UPDATE 7/04/25:
2: Vantive has now completed its own evaluation to determine whether these risks are present with Vantive’s MiniCap Extended Life PD Transfer Sets. These test results demonstrate that there are no PCBs detected when using Vantive’s MiniCap Extended Life PD Transfer Sets with peroxide-cured silicone tubing, and that the levels of PCBAs are not anticipated to present a significant safety risk for patients over 6 months of age. Test results for patients younger than 6 months, however, were inconclusive due to the limitations of available test methodology.
To date, Vantive has not received any complaints related to this problem.
|
| Instructions for Customers/Users |
Update 7/4/25: Vantive is currently in the process of establishing a timeline for the transition to platinum-cured silicone tubing. Once available customers will be offered a replacement.
Problem 1: If transfer sets are still intact and the separation problem is not experienced the device can continue to be used while following aseptic technique. If separation occurs clinics are to replace the transfer set and contact Baxter.
Problem 2:
-For patients older than 6 months of age, healthcare providers are advised to continue using the peroxide-cured silicone tubing version of the MiniCap Extended Life PD Transfer Sets, until such time as replacement devices are available.
-Test results for patients younger than 6 months were inconclusive due to the limitations of available test methodology, therefore healthcare providers should continue to provide dialysis treatments to their patients, as peritoneal dialysis systems are critical to patient care. Accordingly, Vantive recommends that healthcare providers continue to connect the peroxide-cured silicone tubing sets. |
| Action Commencement Date |
11/11/2024 |
| Responsible Entity |
|
| Contact Information |
1800 920 133 - Vantive Pty Ltd |