inforMED
MalfunctionJFL

SYNCHRON® LX CO2 ACID REAGENT

Received Dec 27, 2010 · Event occurred Dec 1, 2010

Report 2050012-2010-01707 · MDR key 1938237

Device

Generic name

Ph Rate Measurement, Carbon-dioxide

Model number

NA

Catalog number

472481

Lot number

M010767

Product problems

  • Leak/Splash

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A SPILL FROM SYNCHRON LX CO2 ACID REAGENT. A TECHNICIAN WAS EXPOSED TO THE SPILLED REAGENT. THE TECHNICIAN FLUSHED THE EXPOSED AREA WITH WATER AND DID NOT GO TO AN EMERGENCY ROOM. NO INJURY WAS REPORTED, AND THERE WAS NO EFFECT TO PATIENT OR USER.

Additional Manufacturer Narrative

THE REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER.

Remedial action

  • Replace