| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2019-RN-00734-1 |
| Product Name/Description |
Alaris System Pump module (LVP) 8100
Alaris System Pump module (LVP) 8100 manufactured between April 2011 and June 2017. That includes FR-110 plastic.
All Alaris Pump module LVP Mechanism Sub Assembly (P/N 10942012)
All Alaris Pump module Bezel Kit Assembly (P/N 10964559)
ARTG: 146664
(Becton Dickinson Pty Ltd - Infusion pump, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/05/2019 |
| Responsible Entity |
|
| Reason/Issue |
Becton Dickinson (BD) is expanding RC-2017-RN-01312-1 to include all bezels manufactured between April 2011 and June 2017. All of the bezels subject to this expansion were manufactured with a specific type of plastic, called FR-110.
The subject of this Product Defect Correction is the bezel assembly. The bezel assembly is the main façade behind the pump module door, where the pump administration set is loaded. The issue involves a potential separation of the bezel posts that connect the mechanism frame to the bezel assembly. If multiple bezel posts are broken, the position of the pumping and / or occlude fingers may shift. Separation of one or more bezel posts that connect the mechanism assembly to the bezel assembly may prevent the device from delivering an accurate amount of fluid through the pumping cycle resulting in an over or under infusion.
BD is not aware of any reports of injury attributed to this defect in Australia. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
BD has assessed the risk of this issue and determined that the affected product can still be used until this correction is carried out. However, BD strongly recommends that clinicians increase their level of vigilance when using impacted pumps. Additionally, clinicians should remove the pump from service if it shows signs of infusion at an unexpected rate. Use non-affected, or remediated, devices in high risk areas if possible. BD is prioritising remediation efforts based on risk.
BD will replace the mechanical assembly of the affected serial numbers at no charge. BD will be in contact with all affected customers to initiate the scheduling process for the remediation.
Update Aug 2019:
Until the remediation, customers should inspect bezels for both priority 1 and priority 2 as soon as feasible per the Service Bulletin provided to facilities. If damage is found during the inspection, the pump should be removed from service and BD should be contacted for replacement bezels. |
| Contact Information |
1300 729 258 - BD Customer Service |