COMPANY ANNOUNCEMENT
Smiths Medical Issues Urgent Medical Device Correction Letter Notifying Customers of Potential Issues with CADD™ Infusion System Infusion Sets for Use with CADD Pumps
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
- Reason for Announcement:
-
Recall Reason DescriptionPotential lack of delivery or underdelivery and false no disposable attached (NDA) alarms.
- Company Name:
- Smith’s Medical
- Brand Name:
-
Brand Name(s)Smith’s Medical
- Product Description:
-
Product DescriptionCADD Infusion System Infusion Sets for use with CADD pumps
Company Announcement
MINNEAPOLIS, Dec. 12, 2022 /PRNewswire/ -- Smiths Medical issued an Urgent Medical Device Correction Letter to notify affected customers of two potential issues with CADDTM Infusion System Infusion Sets related to potential lack of delivery or under delivery and false no disposable attached (NOA) alarms. The letter details the issues, the affected items, the required steps to perform, and specific instructions for treatment of patients requiring life sustaining therapy.
The first issue, lack of delivery or under delivery, may occur due to manufacturing variations that can potentially cause the green CADD Flow Stop arm to compress partially occlude the tubing before clinical use. If this happens, there is a potential that the occlusion does not resolve when the CADD reservoir or administration set is connected to the pump, and the pump may not detect the occlusion. This may result in under delivery or non-delivery of medication, despite the pump displaying that the infusion is running properly.
The second issue, false "no disposable attached" (NOA) alarms, is specific to CADD-Legacy pumps, which Smiths Medical announced the discontinuation of sale effective December 31, 2022. There is a potential that CADD-Legacy pumps may not detect that 50 ml and 700 ml CADD Medication Cassette Reservoirs with Flow Stop are attached to the pump when they are properly attached. When this happens, the pump will initiate an NOA alarm if the NOA double-beep warning is not resolved within 2 minutes. The user must clear the alarm and resolve the cause of the NOA event before using the pump. This issue does not impact 250 ml Flow-Stop and non-Flow Stop CADD Medication Cassette Reservoirs.
A copy of the customer notification, which outlines the potential risks associated with both under delivery and NDA alarms, lists the affected products, and provides specific actions users should take in the event of such occurrences, can be found here.
For further inquiries, please contact Smith Medical using the information provided below.
| Smiths Medical Contact | Contact Information | Areas of Support |
|---|---|---|
| Global Complaint Management | globalcomplaints@smiths-medical.com 1-(866)-216-8806 |
To report adverse events or product complaints |
| Technical Assistance | 1-(800)-258-5361 | Additional information or technical assistance |
The U.S. Food and Drug Administration (FDA) has been notified of this action.
If you wish to contact the FDA regarding any adverse events or quality problems associated with this notice, use the following contact information.
- www.fda.gov/medwatch
- 1-(888)-1NFO-FDA
Media Contact:
Tom McCall
949-366-4368
tom.mccall@icumed.com
SOURCE ICU Medical, Inc.