CADD- SOLIS COMM MODULE
Received Dec 12, 2024 · Event occurred Jun 25, 2024
Report 3012307300-2024-14826 · MDR key 20920337
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Smiths Medical Asd, Inc.Catalog number
21-2131-01
Lot number
18766925
Product problems
- Wireless Communication Problem
- Wireless Communication Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE INSTALLATION, WHEN THE PUMP AND WIRELESS MODULE WERE PAIRED TOGETHER, IT KEPT HAVING INTERMITTENT CONNECTION TO MODULE ERROR. THE PRODUCT FAULT OCCURRED DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
ONE DEVICE WAS RECEIVED ALONG WITH THE HOST PUMP TO BE EVALUATION TOGETHER. EVALUATION FOUND THE FAILURE OCCURRING INTERMITTENTLY WHEN THE COMM MODULE IS TESTED ON ITS HOST PUMP WITH AC POWER ADAPTER PLUGGED IN AND THE POLE MOUNT CAPTURE SECURED TO THE MODULE; BUT NOT REPEATING WHEN A KNOWN GOOD TEST SOLIS PUMP WAS SWAPPED. DETERMINED THE HOST PUMP WAS CONTRIBUTING TO THE FAILURE.