MalfunctionMRZ

MEDFUSION

Received Apr 23, 2021

Report 3012307300-2021-03421 · MDR key 11719081

Device

Generic name

Syringe Pump

Manufacturer

St Paul

Model number

4000

Catalog number

4000-0105-51

Product problems

Device Alarm System
Failure to Sense
Device Alarm System
Failure to Sense

Patient

Not reported

Insufficient Information
Insufficient Information

Narrative

Additional Manufacturer Narrative

INVESTIGATION COMPLETED ON A SMITHS MEDICAL SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 4000 REPORT OF SYSTEM FAILURE WAS CONFIRMED UPON POWERING UP AND REVIEWED IN THE EVENT LOG. THIS WAS ISOLATED TO UNABLE TO UPLOAD NEW CONFIGURATION FROM BASE TO TOP. ACTION WAS TAKEN TO UPLOAD NEW SOFTWARE CONFIGURATION. CRACK WAS NOTED ON LEFT LOWER CORNER OF TOP CASE AND ALSO RIGHT PLUNGER CASE. DEVICE PASSED ALL FUNCTIONAL TESTING.

Description of Event or Problem

INFORMATION RECEIVED A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 4000 PUMPS ALARMED "SYSTEM FAILURE." NO PATIENT ADVERSE EVENTS WERE REPORTED.