MalfunctionMRZ
CADD COMMUNICATION MODULE
Received Feb 14, 2025 · Event occurred Jan 14, 2025
Report 3012307300-2025-01843 · MDR key 21384702
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Smiths Medical Asd, Inc.Catalog number
21-2131-01
Lot number
19808905
Product problems
- Failure to Infuse
- Wireless Communication Problem
- Failure to Infuse
- Wireless Communication Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE MODULE PRODUCES ¿POOR CONNECTION TO MODULE¿ RED-SCREEN ERRORS OR PUMPS BOOT UP AND SHOW NO CHARGE. THERE WAS NO PATIENT INVOLVEMENT.