CADD
Received Nov 13, 2024 · Event occurred Oct 17, 2024
Report 3012307300-2024-13215 · MDR key 20674096
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Icu Medical, Inc.Catalog number
21-2131-01
Lot number
194444982
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 THE DEVICE HAD AN INTERMITTENT CONNECTIVITY ERROR. IT WAS OUT OF BOX FAILURE. THE EVENT OCCURRED UPON OPENING AT A WAREHOUSE. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
DEVICE NOT RECEIVED BY MANUFACTURER. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
CORRECTED: D3 - MFG ESTABLISHMENT NAME, MANUFACTURING PLANT ADDRESS 1, CITY AND ZIP CODENO PRODUCT WAS RETURNED. THE REPORTED ISSUE CANNOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.