CADD SOLIS PUMP
Received Dec 3, 2024 · Event occurred Jul 16, 2024
Report 3012307300-2024-14335 · MDR key 20836218
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
H4.: DEVICE MFG DATE: THE REPORTED, LOT#: 19009199 COULD NOT BE FOUND, FOR THE REPORTED CATALOG#: 21-2131-01. THEREFORE, THE MANUFACTURING DATE COULD NOT BE DETERMINED. ONE DEVICE WAS RECEIVED, FOR EVALUATION. FUNCTIONAL TESTING WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. HOWEVER, REVIEW OF EVENT HISTORY LOG CONFIRMED, OCCURRENCE OF THE FAILURE.
Description of Event or Problem
IT WAS REPORTED, THAT DURING THE IMPLEMENTATION. THE INTERMITTENT WIRELESS COMMUNICATION MODULE HAD A CONNECTION ISSUE. THE PRODUCT FAULT OCCURRED UPON OPENING. THIS WAS AN OUT OF BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT.