CADD SOLIS PUMP
Received Feb 28, 2025 · Event occurred Jan 3, 2025
Report 3012307300-2025-02295 · MDR key 21496534
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Smiths Medical Asd, Inc.Catalog number
21-2111-0401-51
Product problems
- Device Alarm System
- Device Alarm System
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ONE DEVICE WAS RETURNED FOR ANALYSIS. FUNCTIONAL AND VISUAL TESTS WERE PERFORMED, AND THE REPORTED ISSUE WAS NOT DUPLICATED. ALL TESTS PASSED WITHIN SPECIFICATIONS. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.
Description of Event or Problem
IT WAS REPORTED THAT THE ALARM SHOULD SOUND FOR AT LEAST 2 MINUTES, AND IT STOPS AFTER 1¿18¿. BATTERY FALLOUT ALARM TEST FAILED. NO PATIENT INVOLVEMENT.
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.