CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Int

FDA device recall Z-2419-2024 · posted 2024-08-03 · Open, Classified

Recall details

Recalling firm

Smiths Medical ASD Inc.

Reason for recall

CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air Detector, 4. Single Bubble Air Detection, 5. Error Codes Not Displayed at Power Up, 6. Audible Alarm, 7. Low Sensitivity Air in Line Detection Threshold, 8. PharmGuard Server Password. Smiths Medical corrected many of the issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent CADD software (v4.3 - 2023) installed on your pumps.

Action taken

Smiths medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/27/2024 via letter distributed using traceable means. The notice explained the issues affecting the devices, potential risks, and requested the following: "Required Actions for Users: 1. Locate all affected pumps in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations. 2. Complete and return the attached Response Form to smithsmedical3563@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification, even if you do not have the affected product. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to smithsmedical3563@sedgwick.com Follow up Actions by Smiths Medical: Smiths Medical is sending this notification to all affected CADD-Solis customers and is addressing the issues described in this notice through software updates. Smiths Medical will contact you to schedule the implementation of the software updates." For questions contact: 1. Additional information or technical assistance: TSC.Support@icumed.com; 1-800-241-4002, option 3, 4 (M-F, 8:00 am 6:00 pm CT) 2. Questions about this Field Correction Notice: icumed.custhelp.com/app/market-action

Root cause

Software Manufacturing/Software Deployment

Status

Open, Classified

Product code

MEA

Quantity affected

9284 units

Distribution

Worldwide

Date initiated

2024-02-27

Date posted

2024-08-03

Location

Minneapolis, MN

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