inforMED
MalfunctionCBL

AMSORB PLUS CAN-CAN ABSORBER

Received Jun 30, 2006 · Event occurred Jun 29, 2006

Report 733480 · MDR key 733480

Device

Generic name

Anesthesia Absorber

Model number

*

Catalog number

AMAB3800

Lot number

100406F31

Product problems

  • Air Leak
  • Component Incompatible
  • Design/structure problem
  • Disassembly
  • Dislodged
  • Inadequacy of Device Shape and/or Size
  • Out-Of-Box Failure

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

THE AMSORB CAN-CAN ABSORBER IS MARKETED AS A SUBSTITUE FOR THE GE DISPOSABLE MULTI ABSORBER, REF 8003138. WE HAVE BEEN USING THEM WITH THE GE AISYS ANESTHESIA MACHINE. IN SEVERAL INSTANCES, WE HAVE ENCOUNTERED EXTREME DIFFICULTY MOUNTING THE AMSORB UNIT ON THE AISYS MACHINE. IT WOULD APPEAR THAT INSIDE DIAMETER OF THE WATER TRAP PORTION (AND POSSIBLY THE OTHER PORTS) ARE TOO SMALL, MAKING IT DIFFICULT TO ATTACH AND POSSIBLY DAMAGING THE O-RING. COMPARING OF THE AMSORB CANISTER TO THE GE CANISTER, THE O-RING THAT SEALS THE WATER TRAP IS VISIBLY MUCH MORE COMPRESSED BY THE AMSORB CANISTER. IN ADDITION, WE HAVE HAD PROBLEMS WITH THE CANISTER BECOMING DISLODGED DURING USE. THE LUGS THAT HOLD THE CANISTER IN PLACE APPEAR TO BE SHORTER THAN THE GE VERSION, CONTRIBUTING TO THE PROBLEM. IN SEVERAL CASES, THE CANISTER "POPPED OFF" DURING THE LEAK TEST. THE DIAMETER OF THE AMSORB CANISTER IS ALSO MUCH LARGER, AND TOUCHES AGAINST PART OF THE ANESTHESIA MACHINE, POSSIBLY PREVENTING PROPER ALIGNMENT OF THE PORTS AND LOCKING MECHANISM. THE DEVICE IS SUSPECTED OF CAUSING CIRCUIT LEAKS IN SOME CASES. IT IS ALSO POSSIBLE TO MOUNT THE CANISTER BACKWARD IN THE MACHINE AND THIS HAS BEEN OBSERVED IN ONE CASE.