WIRELESS COMMUNICATION MODULE
Received Apr 10, 2025 · Event occurred Mar 1, 2025
Report 3012307300-2025-04089 · MDR key 21813266
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Icu Medical Asd, Inc.Catalog number
21-2131-01
Lot number
UNKNOWN
Product problems
- Failure to Infuse
- Wireless Communication Problem
- Failure to Infuse
- Wireless Communication Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D3 - MFR ESTABLISHMENT NAME: CORRECTION. H6. CODES: UPDATED. DEVICE EVALUATION: COMPLAINT FOR THE FAILURE MODE "WIRELESS MODULE INTERMITTENT CONNECTION WITH THE PUMP" COULD NOT BE CONFIRMED AS NO SAMPLES OR PICTURES WERE PROVIDED BY THE CUSTOMER. WITHOUT THE RETURN OF THE SAMPLE(S) A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.
Additional Manufacturer Narrative
D9: UNKNOWN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
A COMMUNICATION MODULE WAS RETURNED FOR EVALUATION AND DURING TESTING WAS OBSERVED TO ALARM, "WIRELESS MODULE INTERMITTENT CONNECTION WITH THE PUMP." THE DEVICE FAILED TO ASSOCIATE WITH A WIRELESS ACCESS POINT WHEN TURNED ON WITH THE AC POWER CONNECTED. THERE WAS UNKNOWN PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.