MEDFUSION
Received Apr 8, 2021 · Event occurred Mar 1, 2021
Report 3012307300-2021-02914 · MDR key 11634013
Product problems
- Device Alarm System
- Device Alarm System
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
INVESTIGATION COMPLETED ON A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 3500 PUMPS ALARMING SYRINGE PLUNGER NOT IN PLACE WAS CONFIRMED. THIS WAS IN THE EVENT LOG AND CONFIRMED DURING TESTING THE CAUSE WAS RELATED TO Q1 BROKEN OFF FROM THE BOARD, NO GLUE FOUND ON PLUNGER BOARD. PHYSICAL CONDITION OF DEVICE REVEALED COUNTERFEIT TOP AND BOTTOM CASES ARE FOUND ON THE DEVICE. ACTION WAS TAKEN TO REPLACE PLUNGER BOARD, DEVICE THEN PASSED TESTING.
Description of Event or Problem
INFORMATION RECEIVED A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 3500 PUMPS WERE ALARMING SYRINGE PLUNGER NOT IN PLACE. NO PATIENT ADVERSE EVENTS REPORTED.