| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01153-1 |
| Product Name/Description |
Sapphire Multi-Therapy and Sapphire Epidural Pumps with software versions 11.00 and below
Hospira List Numbers:163113601 and 163123601
Q Core Number (on pump): 15031-000-0001 and 15032-000-0001
ARTG Number: 201499 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
There may be a delay in delivery of pain medication when using Epidural mode with patient bolus on Sapphire Multi-Therapy & Sapphire Epidural pumps that have software v11.00 or lower installed. On these pumps, this delay can only occur if the user attempts to start the infusion without first opening the clamp.
Under specific conditions, if a treatment that is programmed in Epidural mode is started by the user without the user opening the clamp, the pump may not detect an occlusion. This resultant potential delay in therapy may happen, if, and only if, all of the following conditions occur concurrently:
A. The clamp is left closed at the “start” of the treatment; and
B. The treatment is set at Epidural mode; and
C. The programmed treatment is set to “bolus only”, i.e., the basal rate=0;
This specific combination of conditions may only occur with pumps that have software v11.00 or lower. There is a potential risk of delay in the pain therapy. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hospira is advising users to upgrade software on the affected devices. Additionally, Hospira is reminding users to ensure the clamp is open when starting an infusion. This action has been closed-out on 06/09/2016. |
| Contact Information |
1300 046 774 (Option 1) - Hospira |