CADD PUMP COMMUNICATION MODULE
Received Sep 17, 2024 · Event occurred Aug 1, 2024
Report 3012307300-2024-09372 · MDR key 20240224
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Smiths Medical Asd, Inc.Catalog number
21-2131-01
Lot number
15863832
Product problems
- Failure to Infuse
- Failure to Infuse
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. THE ROOT CAUSE WAS UNABLE TO BE ESTABLISHED. 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
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 DEVICE ALARM STATES UNUSABLE BATTERY, PUMP WOULD NOT RUN. PER REPORTER, THE ISSUE OCCURRED PRIOR TO INFUSION. THERE WAS NO PATIENT INVOLVEMENT.