Devices

Smiths Issues 3 Recalls on Infusion Pumps

FDA is announcing three Class 1 recalls (device corrections) by Smiths Medical related to certain CADD [computerized ambulatory delivery device]-Solis Ambulatory Infusion Pumps and CADD-Solis VIP Ambulatory Infusion Pumps. Smiths Medical has notified affected users about the following corrections:

Infusion Pump False Occlusion Alarm: Under certain conditions, a CADD-Solis pump may trigger an erroneous (false) Upstream Occlusion (USO) Alarm. The erroneous alarm may occur when there is a delay of more than one hour between the first prime or infusion of a new CADD administration set and the next prime or infusion of the same CADD administration set. The USO Alarm is a high-priority alarm that will interrupt an ongoing infusion or delay initiation of an infusion. The pump cannot resume or start an infusion until the alarm is cleared.
Infusion Pump Thermal Damage Issue: Damage to the rechargeable battery pack circuit board, wireless communication circuit board, or battery separators is associated with the potential for thermal damage in affected infusion pumps. Damage to or inoperable batteries may lead to a delay in therapy or interruption of therapy.
Infusion Pump Intermittent Connection Issue: CADD-Solis pumps may lose communication with the CADD wireless communication module if wireless network setting changes on the hospital network are not compatible with the CADD wireless communication module. This may result in a “wireless module intermittent connection” high-priority alarm, which will stop an ongoing infusion.

An FDA recall notice says that potential health consequences of the issues include interruptions or delays of therapy, which can lead to serious patient injury or death. To date, Smiths Medical has not reported any serious injuries or deaths associated with the issues, it adds.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome