HPS Pharmacies wish to give notice that Smiths Medical, in consultation with the Therapeutic Goods Administration (TGA), has issued a product defect alert for CADD™ Infusion System Disposables as follows:

CADD™ Infusion System Disposables

ARTG 145297 and 316997

This product defect alert has been initiated due to two potential issues.

Issue 1: Lack of delivery or under-delivery related to tubing occlusion.

This error may occur despite the pump displaying that the infusion is running properly.

This issue affects specified medication cassette reservoirs with flow stop and administration sets used with all CADD™ pumps (see Table 1 for details, pages 6-8).

Issue 2: False “No disposable attached (NDA)” alarms.

There is a potential that CADD-Legacy pumps may not detect a properly attached CADD Medication Cassette Reservoirs with Flow Stop. In these cases, the pump will issue an NDA alarm which the user must clear before using the pump.

This issue affects specified 50 mL and 100 mL medication cassette reservoirs with Flow Stop used with CADD™ Legacy Infusion Systems (see Table 2 for details, page 8). This issue does not impact 250 mL Flow-Stop and non-Flow Stop CADD Medication Cassette Reservoirs.

The above issues have the potential to cause serious patient harm. Smiths Medical advises that affected products should not be used to deliver life sustaining medications.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Further information is available:

Should you require further information regarding this matter, please contact Smiths Medical on 1800 654 949, or your pharmacist at HPS Pharmacies.

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