| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01146-1 |
| Product Name/Description |
Graseby 3300 Pump and Graseby 3000 Series Accessories
Graseby 3300 Pumps
Model Number: 0128-0001
Lock Assembly
Model Number: 0128-0025
Pole Clamp
Model Number: 0128-0135 and 0128-0136
Security Cover Kit
Model Number: 0128-0451
ARTG Number: 122405 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Smiths Medical has become aware that in certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key. Affected products were either serviced or manufactured between 30 Oct 2015 and 06 Apr 2016.
In affected cases, the key provided will operate the lock, but cannot be shared between affected pumps and other Graseby 3300 pumps as it should. The key is needed to unlock the pump’s security cover to allow programming of infusion, changing of program settings, restarting infusion or allow clinician overrides. It is also required for operation of the ratcheting type pole clamp (described as the “locking” type): the lock must be operated to remove the pump from the pole and to reposition the pump on the pole.
A mismatch between the lock and key has the potential to delay the delivery of pain medication and lead to an increase in pain. To date, Smiths Medical has not received any reports of serious injuries related to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. Complete and return the supplied Form even if you do not have any affected devices in your possession.
2. Locate all keys associated with GRASEBY pumps and locking accessories and visually inspect keys to ensure keys are labelled “95001”. Collect and isolate any keys not labelled “95001”.
3. Ensure all personnel with Graseby keys are using key “95001”.
4. Using the “95001” key, unlock and relock the locking mechanism on all GRASEBY pumps or locking accessories.
5. If the “95001” key does not successfully operate the locking mechanism, or if you do not have a “95001” key, discontinue use of the pump.
6. Return affected keys to Smiths Medical Australasia. A representative will contact you about scheduling replacement of the affected key.
7. Notify anyone to whom you have distributed this product.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 654 949 - Smiths Medical Customer Service |