| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00140-1 |
| Product Name/Description |
Alaris System Pump module (LVP) 8100 and Air-In-Line (AIL) Sensor Kits
Alaris System Pump module (LVP)
Model: 8100
Manufactured between October 2011 and June 2015
ARTG Number: 146664
Air-In-Line (AIL) Sensor Kits
Part Numbers: 147083-102, 49000221
Distributed between October 2011 and June 2015
ARTG Number: 146664 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has received reports of Air-in-Line (AIL) alarms that have occurred when no air is observed in the line. While the pump is infusing, the system may indicate that an AIL alarm has occurred when no air is in the line. In some cases, these false AIL alarms may be attributed to a faulty AIL sensor.
To date, BD is not aware of any report of injury attributed to this defect in Australia. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
If AIL alarm occurs, the user should do the following:
1. Determine if there is air visible in the tubing that has caused the alarm. If there is air visible in the line, clinician can evaluate whether or not it is clinically significant and remove it according to hospital protocol, if necessary.
2. If no air is observed, ensure that tubing is properly installed in AIL Detector. False AIL alarms may occur if tubing is not properly installed. When inserting the tubing into the AIL detector, use a fingertip and firmly push the tubing toward the back of the AIL detector.
3. If AIL alarms continue to reoccur on the same pump, after air has been removed from the line and tubing has been properly loaded, the AIL sensor may be faulty. If the AIL sensor needs to be replaced, BD will provide replacement parts at no charge. If a pump has been identified as having recurring AIL alarms without evidence of air in the line, then replace the AIL sensor with a new AIL sensor provided by BD.
This action has been closed out on 16/11/2021 |
| Contact Information |
02 9624 9033 - CareFusion Australia 316, a BD company |