Becton Dickinson Bodyguard Infusion Pump Systems (ICN 1355)

MHRA Ref: TBA
Recall Ref: 44

Alert:

• A Field Safety Notice has been issued by Becton Dickinson (CME/BD) UK Ltd regarding the BodyGuard Infusion Systems.
• The Field Safety Notice affects the pumps and associated dedicated administration sets.
• This is an advisory notice due to potential flow rate issues when using the CME/BD BodyGuard™ Microsets/Bodysets Infusion sets with the associated CME/BD BodyGuard™ Infusion Pump.
• The supplier investigation showed an increased risk of under-infusion when using the pump system at high flow rate settings in both continuous and an intermittent infusion, like PCA mode.

Products Affected:

• Please see our Downloads ▼ section to refer to the product listing for further information on the affected product codes.

Impact and Next Steps:

Read the Field Safety Notice and share with anyone in your organisation who may use the CME/BD Bodyguard Infusion Pump System.

BD is issuing a Technical Service Bulletin (SB09248) to all service organisations providing instructions to limit these infusion rates in the settings of the pump.

Until the settings are limited on your pump by your service organisation, please follow these instructions:

• Do not use the BodyGuard Infusion Pump if an alternative infusion pump is available.
• Healthcare professionals should evaluate medications, prescribed therapies and patient populations prior to utilising the infusion pump.
• As the device can infuse at rates slower than expected at high flow rates, clinicians administering infusions should assess the fluid container for any volume remaining in the container at the end of the infusion and ensure the total volume of prescribed medication is delivered. The volume to be infused may need to be re-programmed on the device to complete the infusion.

If you chose to use the pump, please ensure you do the following:

• Limit the maximum rate to 800mL/hr when using Continuous Mode on the CME BodyGuard 323, CME BodyGuard 323 Color Vision, CME BodyGuard 121 Twins, CME BodyGuard Quadro, BD BodyGuard™ DUO and BD BodyGuard™ Infusion Systems.
• Limit the maximum rate to 300mL/hr when using an Intermittent Infusion (Bolus) like PCA Mode on all BD BodyGuard infusion Systems.

Complete the customer response form on page four indicating whether you wish the limiting of Maximum Infusion Rate and Bolus rate to be performed by:

• BD (Option 1)
• By your service organisation (Option 2)
• Or that you have no pumps (Option 3)and return it to BodyGuardFieldAction@bd.com as soon as possible, or no later than 30 September 2021.

If you no longer use the product, it is still important that you return the Customer Response Form for reconciliation purposes.

Should you have any further questions, please contact your local BD Representative or your NHS Supply Chain Customer Service Advisor.