PHADIA 1000 INSTRUMENT
Received Jun 30, 2025 · Event occurred May 30, 2025
Report 3004973408-2025-00001 · MDR key 22360018
Device
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
30 YR · Male
- Exposure to Body Fluids
- No Clinical Signs, Symptoms or Conditions
- Exposure to Body Fluids
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
US FIELD SERVICE ENGINEER (FSE) WAS AT A CUSTOMER SITE FOR A SERVICE VISIT. WHILE REPLACING THE VACUUM PUMP ON PHADIA 1000 INSTRUMENT, THE INSTRUMENT WASTE WAS SPLASHED INTO HIS EYES FROM THE WASTE LINE. THE ENGINEER FLUSHED HIS EYES WITH WATER AND AFTER TALKING TO HIS MANAGER, HE FLUSHED HIS EYES FOR AN ADDITIONAL PERIOD OF TIME AS PER HIS MANAGER'S RECOMMENDATION. THE ENGINEER THEN WENT TO AN URGENT CARE FACILITY AND RECEIVED AN EYE EXAM AND BLOOD TEST (HEPATITIS, HIV, ETC.). THE ENGINEER NEEDS TO DO A FOLLOW-UP SCREENING IN ONE MONTH. THIS IS THE FIRST OCCURRENCE OF THIS TYPE OF EVENT. THE COMPLAINT INVESTIGATION IS ONGOING AND NO MALFUNCTION OF THE PHADIA INSTRUMENT HAS BEEN CONFIRMED TILL DATE. THE LIQUID WASTE GENERATED BY PHADIA INSTRUMENTS MAY CONTAIN THE FOLLOWING SUBSTANCES AT LOW CONCENTRATIONS: CMIT/MIT (KATHON), SODIUM AZIDE, SODIUM CARBONATE, SODIUM HYDROXIDE, ALKYL (C12-16) DIMETHYLBENZYLAMMONIUM CHLORIDE, 2-AMINOETHANOL. IN ADDITION TO THE ABOVE SUBSTANCES, IT MAY ALSO CONTAIN HUMAN SERUM.
Description of Event or Problem
US FIELD SERVICE ENGINEER (FSE) WAS AT CUSTOMER SITE FOR A SERVICE VISIT. WHILE REPLACING THE VACUUM PUMP, THE INSTRUMENT WASTE WAS SPLASHED INTO HIS EYES FROM THE WASTE LINE. THE ENGINEER FLUSHED HIS EYES WITH WATER AND AFTER TALKING TO HIS MANAGER, HE FLUSHED HIS EYES FOR AN ADDITIONAL PERIOD OF TIME AS PER HIS MANAGER'S RECOMMENDATION. THE ENGINEER THEN WENT TO AN URGENT CARE FACILITY AND RECEIVED AN EYE EXAM AND BLOOD TEST (HEPATITIS, HIV, ETC).