Product Defect Alert – Veletri® Consumables Kit

Further to DrugAlert volume 833, HPS Pharmacies wish to give notice that Janssen-Cilag, in consultation with the Therapeutic Goods Administration (TGA), has issued a product defect alert for CADD™ Infusion System Disposables as part of the Veletri^® Consumables kit:

Electric Infusion Pump Administration Set
ARTG 329620

This product defect alert has been initiated due to two potential issues with the CADD™ Infusion System Disposables, which are part of the Veletri^® Consumables kit.

Issue 1: Under-delivery due to tubing occlusion, despite the pump displaying that the infusion is running correctly.

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

Affected batches: 200943, 201422, 210114, 210846, 220048, 220519 & 221293.

Janssen advises that affected products should not be used to deliver life sustaining medications. Janssen will coordinate the replacement of impacted stock as new unaffected stock becomes available.

Janssen provides the following workarounds to be used in the interim:

• Prime the set using the pump. If the fluid doesn’t flow properly or takes an abnormally long time to prime, or if the pump displays a higher than expected priming volume, replace the reservoir or set. The priming volume is listed on the packaging for each administration set.
• If a pump displays an NDA alarm, the user can attempt to resolve the alarm by repositioning the CADD Medication Cassette Reservoir while connected to the pump, repositioning the reservoir by disconnecting from the pump and reattaching it to the pump, or replacing the reservoir.

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.

Should you require further information regarding this matter, please contact Janssen on 1800 226 334, or your pharmacist at HPS Pharmacies.

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