MalfunctionJCB
COULTER® DXH CLEANER
Received Dec 17, 2010 · Event occurred Oct 15, 2010
Report 1061932-2010-00292 · MDR key 1930945
Device
Generic name
Cleaning Agent
Manufacturer
Beckman Coulter, Inc.Model number
NACatalog number
628022
Lot number
2627880
Product problems
- Fluid/Blood Leak
- Device Damaged Prior to Receipt by User
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO COULTER DXH CLEANER REAGENT THAT WAS LEAKING UPON RECEIVING. THE CUSTOMER WAS WEARING LAB COAT, GLOVES, AND EYE PROTECTION. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE REQUIRED MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.
Remedial action
- Replace