CADD SOLIS COMM MODULE
Received Apr 18, 2025 · Event occurred Mar 1, 2025
Report 3012307300-2025-04538 · MDR key 21866139
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Icu Medical, Inc.Catalog number
21-2131-25
Lot number
12798149
Product problems
- Failure to Infuse
- Failure to Infuse
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B5: CORRECTION - THERE WAS UNKNOWN PATIENT INVOLVEMENT. B6, B7, D3, G2, H2, H5, H8: CORRECTION. D9: 27-JUN-2025. H3: ONE COMMUNICATION MODULE WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION SHOWED THE PUMP WAS IN GOOD CONDITION. FUNCTIONAL TESTING WAS PERFORMED, AND THE COMMUNICATION MODULE WAS TESTED WITH A KNOWN GOOD CADD DEVICE. THE DEVICE OPERATED NORMALLY, AND NO ISSUES WERE IDENTIFIED. AS THE REPORTED ISSUE COULD NOT BE DUPLICATED, THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED. NO ACTION WAS TAKEN. THE ITEM IS A PURCHASED FINISHED GOOD, AND THE DEVICE HISTORY AND LOT HISTORY IS WITH THE SUPPLIER. THEREFORE, A MANUFACTURING BATCH REVIEW COULD NOT BE PERFORMED.
Additional Manufacturer Narrative
B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. D4 - LOT #: POSSIBLE LOT 12798149. E1 - INITIAL REPORTER PHONE: (B)(6). H3: 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 REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE SCREEN DISPLAYED A RED ERROR MESSAGE 41786 ALONG WITH CONTINUOUS ALARMS. TROUBLE SHOOTING WAS PERFORMED, BUT THE SAME ERROR CODE KEPT APPEARING. THERE WAS NO PATIENT INVOLVEMENT.