MAUDE Adverse Event Report: ARMSTRONG MEDICAL LTD. AMSORB PLUS CARBON DIOXIDE ABSORBER, 1.2 LITERS; AMSORB PLUS UNIVERSAL BUBBLE CAN

Model Number AMAB4001

Device Problems Crack (1135); Device Inoperable (1663); Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/31/2016

Event Type  Injury  

Event Description

A new (to our facility) product, an amsorb plus carbon dioxide absorber, was installed in all four of our operating rooms, 4 identical drager apollo anesthesia machines.In one of the four rooms, during the first 6 hours of use, a crack developed in the top of the amsorb plus absorber casing at the point where a dual flange inserts into the drager apollo machine.This crack, which exceeded 50 liters of fresh gas flow per minute, made positive pressure ventilation (by ventilator or by hand) of an anesthetized pt impossible.Several items are worthy of note: the machine had passed its automated routine daily checkout at 6am.A surgery performed from 0730 to 1000 had no problems with ventilation.Prior to the event surgery, the excessive leak was identified during a routine abbreviated "between surgeries" check out.The leak was not audible or visible (until the amsorb plus canister was removed from the machine); the leak stopped the anesthetic induction process.In an emergency, an abbreviated pressure check would not be performed and the pt would have been anesthetized and positive pressure ventilation would not have been possible.We tested the same amsorb plus product in 2015 and had an identical crack and leak on the first day of use.We asked the manufacturer to improve the strength of the plastic flange at the top of the absorber and did not use the product again until (b)(6) 2016.We have used a different brand of absorber (drager brand) on these drager apollo anesthesia machines for the past 9 years (x 4 rooms = more than 10000 man-days of use) and have never had a single crack or leak of this type.The plastic flange of the amsorb plus absorber is palpably less compliant and more brittle versus the drager brand absorber.Significant stress is placed on the plastic flange of either absorber during installation ("snap into position") and when the absorber is bumped during routine use (bumped by a chair, blood warmer, knee, etc).We spoke with the manufacturer representative in 2015 and on 03/31/2016 and demonstrated the brittleness of the plastic housing of the amsorb plus absorber vs the drager absorber product.The brittle plastic flange of the amsorb plus absorber can be broken with two fingers.The compliant, flexible flange of the drager absorber product cannot be broken with two fingers.The most important finding is that we had two events - one year apart - in two days of use, versus the drager absorber product which has been used for 9 years with no incidents.Last year, we returned the product to the manufacturer; this year, we kept it.The absorber was exposed to routine anesthetic agents for less than 6 hours - on two different occasions with two different anesthesiologists - and developed a potentially life threatening crack and leak in less than 6 hours of use.

• Brand Name: AMSORB PLUS CARBON DIOXIDE ABSORBER, 1.2 LITERS
• Type of Device: AMSORB PLUS UNIVERSAL BUBBLE CAN
• Manufacturer (Section D): ARMSTRONG MEDICAL LTD.; coleraine BT52 1BS; EI BT52 1BS
• MDR Report Key: 5553764
• MDR Text Key: 42309136
• Report Number: MW5061519
• Device Sequence Number: 1
• Product Code: BSF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: AMAB4001
• Device Lot Number: 150216F33
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 95