inforMED
MalfunctionCBL

CARBOLIME

Received Nov 8, 2012 · Event occurred Oct 23, 2012

Report 2854124 · MDR key 2854124

Device

Generic name

Absorbent, Carbon-dioxide

Model number

*

Catalog number

55-01-0025

Lot number

C24912A

Product problems

  • Air Leak
  • Fitting Problem
  • Pressure Problem

Patient

15 MO

  • No Code Available

Narrative

Description of Event or Problem

UPON INTUBATION OF PATIENT, IT WAS DISCOVERED THAT THE ANESTHESIA MACHINE HAD A LEAK AND WOULD NOT HOLD PRESSURE. THE ANESTHESIA WAS UNABLE TO VENTILATE PATIENT AND DELIVER ANESTHETIC GASES. OXYGEN TUBING WAS OBTAINED IMMEDIATELY FROM BED IN HALLWAY AND PATIENT WAS MANUALLY BAGGED THROUGH ENDOTRACHEAL TUBE. AN INTRAVENOUS (IV) CONNECTION WAS OBTAINED SO THAT SEDATING AGENTS COULD BE DELIVERED TO THE INTUBATED PATIENT AND THE CLINICAL ENGINEERING DEPARTMENT (CE) WAS NOTIFIED IMMEDIATELY. CE DIAGNOSED THE PROBLEM IN 10-15 MINUTES. THE SITE OF THE LEAK WAS A CARBOLIME CANISTER AND ROTATING THEM FIXED THE LEAK. THEY WERE ABLE TO CONTINUE THE CASE. HOWEVER, THIS IS THE 3RD TIME IN 5 DAYS WE HAVE HAD PROBLEMS. UPON CLOSER INSPECTION, THE CARBOLIME INSERT IS DISFIGURED AND DO NOT FIT IN THE CANISTERS AS THEY SHOULD. THIS CAUSED THE AIR LEAK. THE INNER CANISTER APPEARED TO BE SLIGHTLY TO LARGE AND IT TOOK A GOOD DEAL OF FORCE TO GET IT TO SEAT PROPERLY. WE RECEIVED TWO MORE CASES WITH LOT# C26312, AND THEY STILL DO NOT WORK. ALSO LOT# C24912A WOULD NOT SEAT PROPERLY. EVENTUALLY WE WERE ABLE TO FIND CANNISTERS WITHIN LOT# C26312 THAT DID FIT LIKE THEY WERE SUPPOSED TO.======================MANUFACTURER RESPONSE FOR CO2 ABSORBENT, CARBOLIME (PER SITE REPORTER).======================AFTER MULTIPLE ATTEMPTS ON NOV 1 I WAS FINALLY ABLE TO REACH THE MANUFACTURER REPRESENTATIVE. SHE STATED THAT THEY WERE AWARE OF THE FIT PROBLEM. I ASKED THEM FOR COMMUNICATION REGARDING WHAT LOT NUMBERS WERE SAFE TO USE AND RECEIVED NO ADDITIONAL COMMUNICATION FROM THEM. WE EVENTUALLY HAD TO FIND A GOOD LOT NUMBER THROUGH TRIAL AND ERROR.