CADD-Solis Ambulatory Infusion Pumps with Software Defects Affecting Device Responsiveness
CADD-Solis Model 2100 infusion pumps with pre-v4.3 software have defects affecting occlusion detection and device responsiveness. Manufacturer recommends updating to software version 4.3 (2023) to resolve the issues.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires minimum severity level 4. Multiple software defects affecting critical infusion pump functions including occlusion detection and device responsiveness could impact medication delivery safety, though no injuries or illnesses have been reported.
Plain-English summary
Smiths Medical ASD Inc. is notifying users of CADD-Solis Ambulatory Infusion Pumps, Model 2100, that pumps with software versions before 4.3 contain multiple defects. This recall affects approximately 9,284 units distributed worldwide.
The software defects include: upstream occlusion detection failure, unresponsive stop and power keys, manual mode air detector issues, single bubble air detection failure, error codes not displayed at power-up, audible alarm problems, low sensitivity air-in-line detection threshold, and PharmGuard Server password issues. These defects could impact the device's ability to detect occlusion and air in the line, as well as responsiveness to user commands.
The CADD-Solis pumps are indicated for intra-arterial, subcutaneous, intraperitoneal, and epidural infusions, as well as therapies requiring continuous or intermittent medication delivery. Patients and healthcare facilities using these pumps are affected.
Healthcare facilities and users should immediately update their CADD-Solis pumps to software version 4.3 (released in 2023), which contains corrections for these defects. Smiths Medical has already incorporated these corrections into all subsequent software releases beyond v4.3.
The recalled product
- Product
- 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…
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 9,284
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF List Number: 21-2101-0200-02
- UDI/DI 30610586035337
- Serial Numbers: 1006964
- 1006966
- 1006969
- 1008404
- 1008405
- 1009451
- 1010631
- 1014398
- 1010689
- 1010420
- 1010442
- 1010443
- 1010444
- 1010445
- 1005368
- 1005365
- 1006283
- 1006298
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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