Recall Z-2419-2024 ยท MEA Pump, Infusion, Pca
Smiths Medical ASD Inc.
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
| Date | Aug 3, 2024 (initiated Feb 27, 2024) |
| Status | Open, Classified |
| Reason | 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 soft |
| Root cause | Software Manufacturing/Software Deployment |
| Action | 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 |
| Quantity | 9284 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072144 | CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR Smiths Medical MD, Inc., Mar 7, 2008 |