Field Safety Notice Smiths Medical CADD™ Infusion System Infusion Sets for use with CADD Pumps (ICN 1968)

NHS Supply Chain Reference: 77

Alert:

• Smiths Medical has issued a Field Safety Notice for two potential issues with CADD Infusion System Infusion Sets.
• Issue 1: Lack of Delivery or Under Delivery Related to Tubing Occlusion.
  • If the tubing is occluded under the Flow Stop arm, the pump cannot detect the occlusion and may not infuse as intended; it may underdeliver the fluid/medication or cause an interruption in therapy, even though the pump will display that the infusion is running properly.

• Issue 2: False “No Disposable Attached (NDA)” Alarms.
  • During infusion, if the pump does not detect the cassette and triggers an NDA alarm, the pump will stop delivery and display “No disposable, clamp tubing,” resulting in an interruption of therapy.

• Please note specific instructions for treatment of patients requiring life sustaining therapy:
  • For infusion of life sustaining medications, use of alternative CADD infusion sets is recommended.

Products Affected:

• There are 13 NHS Supply Chain products affected.
• See our Downloads ▼ section to refer to the product listing for more information on the affected products.
• Details of the lots affected can be found on pages 6 to 8 of the Field Safety Notice.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Immediately identify affected products in your possession and ensure these products are separated and labelled as affected by this FSN to avoid use for life sustaining medications.
• For use with life sustaining medications, please contact Smiths Medical customer service (ukcs@smiths-medical.com) for information on obtaining alternative CADD infusion sets.
• For patients requiring life sustaining medications, use of alternative CADD infusion sets is recommended. Clinicians can contact the specialty pharmacies and discuss availability of alternative CADD infusion sets. Depending on availability and specific patient situations, clinicians may consider switching patients to an alternative pump.
• Please see the attached Product Listing for information on potential indirect alternatives available by NHS Supply Chain.
• Please note that due to the clinical nature of these alternative products we advise you to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.