MEDFUSION
Received Apr 23, 2021
Report 3012307300-2021-03422 · MDR key 11719473
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION COMPLETED ON A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 4000 PUMPS. THE COMPLAINT OF MOTOR NOT RUNNING WAS CONFIRMED DURING A FLOW TESTING AND REVEALED IN THE EVENT LOG. THIS WAS ISOLATED TO MAIN BOARD WAS KNOCKED OUT OF THE EXTRUSION GROVE. THE PHYSICAL CONDITION OF DEVICE VISUALLY REVEALED RIGHT PLUNGER CASE AND PIECE BROKEN OFF. ACTION WAS TAKEN TO REPLACE THE MAIN BOARD INTO THE EXTRUSION CASE AND REPORTED REPLACING BROKEN RIGHT PLUNGER CASE. IN ADDITION REPLACED BOTTOM CASE FOR CONTAMINATION. DEVICE PASSED ALL DELIVERY TESTING.
Description of Event or Problem
INFORMATION RECEIVED A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 4000 PUMPS " MOTOR NOT RUNNING." NO PATIENT ADVERSE EVENT REPORTED.