MEDFUSION 4000 PUMP
Received Apr 1, 2025 · Event occurred Mar 1, 2025
Report 3012307300-2025-03592 · MDR key 21746237
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Smiths Medical Asd, Inc.Catalog number
4000-0106-01
Product problems
- Device Alarm System
- Device Alarm System
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 THERE WAS A PRIMARY AUDIBLE ALARM BGND ERROR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
B3: DATE OF EVENT IS UNKNOWN. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
ONE DEVICE WAS RECEIVED FOR EVALUATION FOR THE COMPLAINT THAT A PRIMARY AUDIBLE ALARM BGND ERROR. THE COMPLAINT CONFIRMED BY CHECKING THE ALARM HISTORY. IT IS VERIFIED THAT THE ERROR IS FOUND IN THE ALARM HISTORY. THERE WAS NO 12-MONTH SERVICE HISTORY DURING THE REVIEW. THE VISUAL AND FUNCTIONAL TESTING WAS PERFORMED. THE PROBABLE ROOT CAUSE WAS THE FAULTY SPEAKER AND WAS REPAIRED BY REPLACING THE SPEAKER. AFTER REPLACING THE PARTS, THE PUMP PASSED ALL THE TESTING AND IS FULLY OPERATIONAL.