SYNCHRON LX CO2 ACID REAGENT
Received Nov 22, 2011 · Event occurred Oct 25, 2011
Report 2050012-2011-07844 · MDR key 2346574
Device
Generic name
Ph Rate Measurement, Carbon-dioxide
Manufacturer
Beckman Coulter, Inc.Catalog number
472481
Product problems
- Leak/Splash
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEY RECEIVED LEAKING CO2 REAGENT. CUSTOMER REQUESTED REPLACEMENT. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED OR REPORTED OUTSIDE THE LABORATORY. CUSTOMER REPORTED THAT NO INDIVIDUAL WAS TREATED MEDICALLY DUE TO EXPOSURE. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.
Additional Manufacturer Narrative
BEC IS FILING THIS REPORT BECAUSE CO2 ACID REAGENT IS CORROSIVE, MAY CAUSE BURNS TO THE EYES, SKIN, RESPIRATORY TRACT AND GASTROINTESTINAL TRACT. STRONG INORGANIC ACID MISTS CONTAINING SULFURIC ACID MAY CAUSE CANCER. (B)(4).