CADD
Received Oct 10, 2024 · Event occurred Jul 25, 2024
Report 3012307300-2024-10876 · MDR key 20423413
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Smiths Medical Asd, Inc.Catalog number
21-2131-01
Lot number
19009199
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 RECEIVED FOR EVALUATION. FUNCTIONAL TESTING WAS UNABLE TO DUPLICATE THE REPORTED ISSUE WHEN CONNECTED TO A KNOWN GOOD OPERATING PUMP; HOWEVER, UPON FURTHER INVESTIGATION, FAILURE OFTEN OCCURS WITH NEWLY BUILT PUMPS. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE ALARMED FOR AN INTERMITTENT WIRELESS MODULE CONNECTION ERROR WHEN CONNECTED TO AC POWER. THE PRODUCT FAULT OCCURRED UPON OPENING. IT WAS AN OUT OF BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT.