inforMED
MalfunctionCBL

AMSORB

Received Jan 11, 2021 · Event occurred Dec 22, 2020

Report 11146550 · MDR key 11146550

Device

Generic name

Absorbent, Carbon-dioxide

Model number

AMAB3801-8

Lot number

230420F112

Product problems

  • Leak/Splash
  • Therapeutic or Diagnostic Output Failure

Patient

Not reported

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

OVER THE LAST COUPLE MONTHS IT HAS BEEN REPORTED AT TWO OF OUR HOSPITALS THAT THE O E MEYER AMSORB CARBON DIOXIDE ABSORBERS HAVE BEEN LEAKING. THIS ISSUE IS IDENTIFIED WHEN THE ANESTHESIA GAS MACHINE DOES NOT PASS ITS LEAK TEST. THE CANISTER IS THEN REMOVED AND REPLACED WITH ANOTHER CANISTER, UNTIL THE LEAK TEST IS PASSED AND THE MACHINE IS WORKING APPROPRIATELY. THIS ISSUE HAS BEEN IDENTIFIED AT BOTH OUR HOSPITAL LOCATIONS AND SEEMS TO PERSIST ACROSS SEVERAL DIFFERENT LOT NUMBERS. THREE OF THE LOT NUMBERS THAT WERE IDENTIFIED TO HAVE THIS ISSUE INCLUDE 170620F51, 17062OF61, AND 230420F112. THE MANUFACTURER REPLACED SOME OF THE AFFECTED PRODUCT.