inforMED
MalfunctionCBL

AMSORB

Received Nov 27, 2000 · Event occurred Nov 27, 2000

Report MW1020482 · MDR key 306054

Device

Generic name

Sodalime

Manufacturer

Abbott Labs

Model number

*

Catalog number

*

Lot number

67009EE

Product problems

  • Loose
  • Replace
  • Fitting Problem

Patient

*

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

PROBLEM WITH PACKAGING. THE CARTRIDGES DON'T FIT TIGHTLY ENOUGH TO KEEP PT'S EXHALED AIR FROM ESCAPING TO OUTSIDE OF CARTRIDGE AND PT RISK IS THAT THEY MAY REBREATHE EXPIRED CO2 CAUSING INSPIRED CO2 TO RISE SIGNIFICANTLY. SEEN ANYWHERE FROM 20 TO 32 INSPIRED CO2 LEVELS. THE CANISTERS HAVE BEEN TAKEN OUT OF SERVICE. WERE BEING USED IN A TRIAL. PT WAS NOT HARMED.