| 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 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.
2: Vantive has 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 |
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 Vantive.
Update 30/09/26 - Problem 2:
Additional toxicological data has since been finalised which concluded that any exposure to peroxide-cured silicone tubing from MiniCap Extended Life PD Transfer sets does not exceed the tolerable limit for patients, regardless of patient age.
However, Vantive would like to provide additional instructions regarding the actions to be taken by customers when treating patients younger than 6 months of age (representative body weight: 3.5kg) and recommends that healthcare providers continue to connect the peroxide-cured silicone tubing sets and prioritise the use of shorter transfer sets if no platinum-cured silicone tubing or other alternatives are available. |
| Action Commencement Date |
11/11/2024 |
| Responsible Entity |
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| Contact Information |
1800 920 133 - Vantive Pty Ltd |