| TGA Action ID |
RC-2025-RN-00597-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Karl 100
GMDN: 36664 Pump, Roller
Serial number: 20020 |
| ARTG Number |
352397 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The Karl 100 is an automated device designed to dispense radiopharmaceuticals into syringes with precision, while minimising radiation exposure to the operator. It is compatible with various Lead Pot models, including the MEDRAD Lead Pot manufactured by Bayer.
In August 2023, a hospital reported a problem with drawing up the radiopharmaceutical. Upon investigation, Cyclomedica determined that the inner "Vial Cap" of the MEDRAD Lead Pot had not been removed during installation—only the outer "Access Cap" had been taken off. This omission prevented the dispensing needle from reaching the bottom of the Lead Pot, particularly when the radiopharmaceutical level was low.
The device manual did not include instructions indicating that both the Vial Cap and Access Cap must be removed for MEDRAD Lead Pots, which contributed to the error.
This market action was undertaken prior to TGA notification. |
| Instructions for Customers/Users |
Customers are to note that the problem was resolved by a Cyclomedica service engineer, who removed the Vial Cap and confirmed the root cause with the manufacturer.
An updated version of the Trouble Shooting document was released. This updated guidance outlined the Lead Pot models compatible with the KARL 100 system and clearly identifies those requiring manual lid removal by the operator.
This action has been closed out on 09/07/2025 |
| Action Commencement Date |
3/07/2025 |
| Responsible Entity |
|
| Contact Information |
0415 188 850 - Mathew Farag, Cyclomedica Australia |