inforMED
MalfunctionCBL

MEDISORB

Received Dec 4, 2024 · Event occurred Aug 8, 2024

Report 20842033 · MDR key 20842033

Device

Generic name

Absorbent, Carbon-dioxide

Manufacturer

Vyaire Medical Oy

Model number

M1173310

Catalog number

M1173310

Patient

70 YR · Female

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

Narrative

Description of Event or Problem

DURING THORACIC SURGERY CASE, ANESTHESIOLOGIST ATTEMPTED TO REPLACE USED SODASORB CONTAINER AS PATIENT WAS STARTING TO HAVE INCREASED INSPIRATION OF CARBON DIOXIDE WHICH COULD BE HARMFUL DURING THE SURGERY. CANISTER WAS REPLACED AND COULD NOT VENTILATE OR OXYGENATE PATIENT. CANISTER REMOVED AND FOUND TO BE CRACKED, USED CONTAINER THEN REPLACED UNTIL ANESTHESIA TECH COULD BRING REPLACEMENT CANISTER. MULTIPLE EVENTS HAVE OCCURRED PREVIOUSLY WITH THESE SAME CANISTERS FROM THE SAME MANUFACTURER WHERE THE REPLACEMENT CANISTER HAS A CRACK IN IT, AND IT IS UNSAFE TO CONTINUE TO USE THESE DEFECTIVE DEVICES WHEN WE DEPEND ON THEIR FUNCTIONING APPROPRIATELY IN THE MIDDLE OF SURGERY.