CADD (infusion pumps)

2022: Manufacturer's recognition of equipment malfunction

On December 12, 2022, Smiths Medical issued an urgent medical device adjustment letter to inform customers of potential problems with the CADD infusion system.

The company, which ICU Medical acquired in January for $2.35 billion, identified two potential problems with infusion kits. These are due to potential lack of delivery or underdelivery and false triggering of the No Single Use Item (NDA) alarm.

Smiths Medical issued an urgent medical device adjustment letter to inform customers of potential problems with the CADD infusion system

According to the press release, the absence or underdelivery may occur due to production deviations. These deviations can compress the green CADD Flow Stop lever. This leads to partial occlusion of the tube before clinical use, experts at Smiths Medical report.

In this case, occlusion may not be eliminated when the CADD reservoir or insertion kit is connected to the pump. The pump may not detect occlusion. This can lead to insufficient delivery or non-delivery of the medicine, even if the pump shows the correct infusion. The company said that the second problem relates specifically to CADD-Legacy pumps. Smiths Medical announced it would stop selling them effective December 31, 2022.

CADD-Legacy pumps may not detect connection to the CADD 50 mL and 100 mL cassette tank pump for flow-stopping drugs. This can happen even with the right joining. When this occurs, the pump initiates an NDA alarm if a double beep alert is not cleared within two minutes.

Users must clear the alarm and correct the cause of the NDA event before using the pump. The problem does not apply to CADD 250 ml medicine cassette tanks with and without the Flow-Stop system.^[1]

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