| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01579-1 |
| Product Name/Description |
CADD Infusion System Disposables as part of the Veletri Consumables kit (Electric infusion pump administration set)
Batch numbers: 200943, 201422, 210114, 210846, 220048, 220519 & 221293
ARTG 329620
(Janssen-Cilag Pty Ltd - Electric infusion pump administration set) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/01/2023 |
| Responsible Entity |
|
| Reason/Issue |
Janssen-Cilag are aware of two potential issues for the CADD Infusion System Disposables, which are part of the Veletri Consumables kit. This action follows the Product Defect Alert by Smiths Medical Australasia in Dec 2022, who is a manufacturer of the CADD Infusion System Disposables.
Issue 1: Manufacturing variations may cause the green CADD Flow Stop arm to compress and partially occlude the tubing before clinical use. This may result in under delivery, despite the pump displaying that the infusion is running properly.
Issue 2: There is a potential that CADD-Legacy pumps may not detect that 50mL and 100mL CADD Medication Cassette Reservoirs with Flow Stop are attached to the pump when the cassettes are properly attached. Manufacturing variations on certain cassette reservoirs may interfere with the pump detecting a properly attached CADD cassette. In this case, the pump will issue a No Disposable Attached (NDA) double-beep audible warning, and delay the initiation of therapy. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Janssen are advising pharmacists, clinicians & patients to use alternate CADD infusion sets for life sustaining medications. Subject to stock availability, the impacted stock will be replaced when new unaffected stock when it becomes available and Janssen will coordinate this process.
Interim work around instructions:
Issue 1: Prime the set using the pump. If the fluid doesn’t flow properly or takes an abnormally long time to prime, or if the pump displays a higher than expected priming volume, replace the reservoir or set. The priming volume is listed on the packaging of each set.
Issue 2: If a pump displays an NDA alarm, The user can attempt to resolve the alarm by repositioning the CADD Medication Cassette Reservoir while connected to the pump, repositioning the reservoir by disconnecting from the pump & reattaching it to the pump, or replacing the reservoir.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 226 334 - Medical Information - Janssen |