inforMED
MalfunctionCBL

AMSORB PLUS

Received Feb 5, 2018 · Event occurred Dec 7, 2017

Report 7240794 · MDR key 7240794

Device

Generic name

Absorbent, Carbon-dioxide

Catalog number

AMAB3801

Lot number

24071F21

Product problems

  • Leak/Splash

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

STAFF FOUND A BAD LOT OF DISPOSABLE ABSORBER CANISTERS THAT WERE CREATING A 700-900 ML/MIN LEAK IN BAG MODE. WE REMOVED ALL OF THE AFFECTED ABSORBER CANISTERS FROM SERVICE. NO HARM TO PATIENTS OR STAFF.