| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00624-1 |
| Product Name/Description |
Sapphire Infusion Pump
Hospira List Number: 163113601/163123601
Q Core Number (on pump): 15031-000-0001 /15032-000-0001
ARTG Number: 201499 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
Q Core (the Sapphire Infusion Pump original Manufacturer) has received complaints from customers that when using the Epidural mode with patient bolus, the amount of medication delivered may be greater than programmed. In the Sapphire pump, as in all infusion systems, external factors may cause fluctuations in flow rate accuracy. Investigation of these complaints determined that the deviation observed is exclusively related to the use of catheters with a gauge smaller than that used for the Sapphire pump flow accuracy calibration. No patient injuries or deaths have been reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
To address this issue, Q Core Medical is providing an addendum to the User Manual to assist customers in (i) identifying whether the catheter utilized may cause over-delivery, (ii) better understanding the effect of back pressure and catheter size on the accuracy of the delivered volume, (iii) translating the catheter’s back pressure to the degree of flow deviation that can be expected, and (iv) contacting Hospira Representative to determine if and to what extent specific catheter/pump combinations are susceptible to over-delivery.
Future versions of the User Manual will incorporate the information contained in the addendum. This action has been closed-out on 30/08/2016. |
| Contact Information |
1300 046 774 - Hospira |