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Class I Recall Notices: Three Infusion Pump Corrections from Smiths Medical
The FDA is aware that Smiths Medical has issued three letters to affected customers that certain CADD-Solis Ambulatory Infusion Pumps and CADD-Solis VIP Ambulatory Infusion Pumps have updated use instructions. Smiths Medical has notified affected users of corrections to the following:
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Infusion Pump False Occlusion Alarm: Under certain conditions, a CADD-Solis pump may trigger an erroneous (false) Upstream Occlusion (USO) Alarm. The erroneous USO 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.
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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. The user would be alerted with the normal “Low Battery” or “Depleted Battery” alarms. The presence of excessive heat from damaged or shorted components is also possible, which may result in a thermal injury.
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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. When this alarm triggers, the pump must be power cycled to clear the alarm.
Potential health consequences of these issues include interruptions or delays of therapy, which can lead to serious patient injury or death, depending on the clinical situation and the type of medication being administered. Smiths Medical has not reported any serious injuries or deaths associated with these issues.
These recalls involve updating instructions for using the devices and does not involve removing them from where they are used or sold. The FDA has identified these recalls as the most serious type. These devices may cause serious injury or death if you continue to use them without following the updated instructions.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about these issues should contact Smiths Medical at globalcomplaints@icumed.com or 1-866-216-8806.
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