MalfunctionCBL

AMSORB® PLUS

Received Jul 6, 2022 · Event occurred Apr 29, 2022

Report 14929024 · MDR key 14929024

Device

Generic name

Absorbent, Carbon-dioxide

Manufacturer

Armstrong Medical Ltd

Model number

AMAB3803GE

Catalog number

2105489-006

Lot number

101221F511

Product problems

Leak/Splash

Patient

Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

AMSORB PLUS DISPOSABLE CANISTERS ARE LEAKING ON THE ANESTHESIA MACHINES. MANUFACTURER RESPONSE FOR AMSORB PLUS DISPOSABLE CANISTER, AMSORB PLUS PREFILLED CARE-CAN ABSORBER CANISTER, 1.4L, 8 PER CASE (CARESTATION) (PER SITE REPORTER). HELLO, TODAY WE TESTED (2) AMSORB PLUS CANISTERS THAT HAD BEEN SET ASIDE. ONLY (1) FAILED THE SELF-CHECK. THE OTHER CANISTER PASSED. I DROPPED OFF (3) REPLACEMENT CANISTERS AND TOOK THE (1) BAD ONE. I HAVE REPORTED THE LOT NUMBER 101221F511 TO THE GE TEAM. I WILL LET YOU KNOW IF THERE IS A KNOWN ISSUE TIED TO LOT 101221F511.