Safety Report: Smith’s Medical CADD Infusion System Infusion Sets for use with CADD pumps - recalled due to alarms issues, USA

United States

Smiths Medical issued an Urgent Medical Device Correction Letter to notify affected customers of two potential issues with CADDTM Infusion System Infusion Sets related to potential lack of delivery or underdelivery and false no disposable attached (NOA) alarms. The letter details the issues, the affected items, the required steps to perform, and specific instructions for treatment of patients requiring life sustaining therapy.

The first issue, lack of delivery or underdelivery, may occur due to manufacturing variations that can potentially cause the green CADD Flow Stop arm to compress partially occlude the tubing before clinical use. If this happens, there is a potential that the occlusion does not resolve when the CADD reservoir or administration set is connected to the pump, and the pump may not detect the occlusion. This may result in underdelivery or non-delivery of medication, despite the pump displaying that the infusion is running properly.

The second issue, false "no disposable attached" (NOA) alarms, is specific to CADD-Legacy pumps, which Smiths Medical announced the discontinuation of sale effective December 37, 2022. There is a potential that CADD-Legacy pumps may not detect that 50 ml and 700 ml CADD Medication Cassette Reservoirs with Flow Stop are attached to the pump when they are properly attached. When this happens, the pump will initiate an NOA alarm if the NOA double-beep warning is not resolved within 2 minutes. The user must clear the alarm and resolve the cause of the NOA event before using the pump. This issue does not impact 250 ml Flow-Stop and non-Flow Stop CADD Medication Cassette Reservoirs.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Smith’s Medical
Brand name: Smith’s Medical
Product recalled: CADD Infusion System Infusion Sets for use with CADD pumps
Reason of the recall: Potential lack of delivery or underdelivery and false no disposable attached (NDA) alarms.
FDA Recall date: January 05, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smiths-medical-issues-urgent-medical-device-correction-letter-notifying-customers-potential-issues