MalfunctionMRZ
MEDFUSION
Received May 13, 2021
Report 3012307300-2021-04287 · MDR key 11816509
Product problems
- Device Alarm System
- Device Alarm System
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 SYRINGE INFUSION PUMPS/MEDFUSION 3500 PUMP COMPLAINT OF FAIL SAFE MOTOR RUN AWAY WAS REVEALED IN THE EVENT LOG AND DURING FUNCTIONAL TESTING. THIS WAS ISOLATED TO THE MAIN PC BOARD NO LONGER OPERATING PROPERLY, WHICH IS REVEALED TO BE NORMAL WEAR. ACTION WAS TAKEN TO REPLACE THE MAIN PC BOARD AND UPLOAD NEW SOFTWARE. DEVICE IS IN GOOD CONDITION.
Description of Event or Problem
INFORMATION RECEIVED A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 3500 PUMPS COMPLAINT OF FAIL SAFE MOTOR RUN ERROR. NO PATIENT ADVERSE EVENTS REPORTED.