MalfunctionMRZ
MEDFUSION
Received Apr 8, 2021
Report 3012307300-2021-02976 · MDR key 11637408
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 FLANGE SENSOR ERROR WAS CONFIRMED IN EVENT LOG AND UPON POWERING UP DEVICE. PHYSICAL CONDITION OF DEVICE REVEALED PLUNGER CASE SEAL WAS DAMAGED. THE CAUSE OF EVENT WAS ISOLATED TO CONTAMINATION BETWEEN THE CASE AND EAR CLIP. ACTION WAS TAKEN TO REMOVE THE CONTAMINATION.
Description of Event or Problem
INFORMATION RECEIVED A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 3500 ALARMED FLANGE SENSOR ERROR.NO PATIENT ADVERSE EVENTS REPORTED.