AMBULATORY PUMP PERIPHERALS
Received Apr 16, 2025 · Event occurred Dec 2, 2024
Report 3012307300-2025-04339 · MDR key 21849618
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Icu Medical, Inc.Catalog number
21-2131-25
Lot number
18489537
Product problems
- Device Alarm System
- Wireless Communication Problem
- Device Alarm System
- 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 PUMP HAD A WHITE SCREEN WITH SOUND ERROR CODE: 41100. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
D4 - LOT #: CORRECTION. D9: DATE RETURNED TO MFG.: 6/13/2025. D3 - MFG ESTABLISHMENT NAME, H3 AND H6. CODES: UPDATED. DEVICE EVALUATION: THE COMMUNICATION MODULE WAS RETURNED WITH NO VISUAL DAMAGE. THE DEVICE WAS POWERED ON AND DISPLAYED A BATTERY LEVEL OF 100%. IT SUCCESSFULLY CONNECTED TO THE LOCAL WI-FI NETWORK WITHOUT ANY ERRORS. BASED ON THE REPORTED ISSUE "PUMP WHITE SCREEN AND SOUND ERROR CODE: 41100" THE PROBLEM DOES NOT APPEAR TO BE RELATED TO THE COMMUNICATION MODULE. UNABLE TO CONFIRM COMPLAINT OR DETERMINE PROBABLE CAUSE. THE ITEM IS A PURCHASED FINISHED GOOD, AND THE DEVICE HISTORY RECORD (DHR) IS WITH THE SUPPLIER THEREFORE, A MANUFACTURING REVIEW COULD NOT BE PERFORMED.