CADD
Received Dec 27, 2024 · Event occurred Dec 1, 2024
Report 3012307300-2024-15536 · MDR key 21028431
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Smiths Medical Asd, Inc.Catalog number
21-2131-25
Lot number
12798149
Product problems
- Wireless Communication Problem
- Wireless Communication Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D9 - DATE RETURNED TO MFG: 1/27/2025. ONE DEVICE WAS RETURNED FOR ANALYSIS. FUNCTIONAL AND VISUAL TESTS WERE PERFORMED, AND THE REPORTED ISSUE WAS NOT DUPLICATED. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.
Additional Manufacturer Narrative
A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE HAD WIRELESS MODULE INTERMITTENT SIGNAL WITH THE PUMPS. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.