CADD
Received Dec 10, 2024 · Event occurred Jun 1, 2024
Report 3012307300-2024-14639 · MDR key 20895355
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Smiths Medical Asd, Inc.Catalog number
21-2131-01
Lot number
18798551
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
ONE DEVICE WAS RETURNED WITH ITS HOST PUMP AND EVALUATED TOGETHER. EVALUATION COULD NOT DUPLICATE THE REPORTED FAILURE AFTER ALL ATTEMPTS WERE MADE AND REVIEW OF EVENT HISTORY LOG CONFIRMED OCCURRENCE OF THE FAILURE. BASED ON THE EVALUATION RESULTS, NO FAULT WAS FOUND WITH THE WIRELESS CONNECTIVITY FUNCTIONS OF THE COMM MODULE.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE ALARMS FOR INTERMITTENT CONNECTION BETWEEN MODULE AND PUMP, THIS WAS AN OUT OF BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT.