MalfunctionCKA
SYNCHRON AST KIT
Received Dec 10, 2010 · Event occurred Nov 15, 2010
Report 2050012-2010-01640 · MDR key 1919007
Device
Generic name
Ast Kit
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
476831
Lot number
Z008006
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER WAS SENT REPLACEMENT.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT REAGENT CARTRIDGES WERE LEAKING AT THE SEAM. NO INJURY WAS REPORTED.
Remedial action
- Replace