MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2006-09-01 for AMSORB PLUS CAN-CAN AMAB3800 manufactured by Armstrong Medical Ltd..
[20509529]
The amsorb can-can absorber is marketed as a substitute 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 had been observed in one case. Device usage problem: device failed/was hard to use.
Patient Sequence No: 1, Text Type: D, B5
[20808716]
It is our understanding that users have experienced difficulties with the method of engagement of the ge multi absorber with the aisys machine and in other models where the absorber canister is inverted for placement. We belive that these issues prompted ge to redesign a portion of the aisys machine to include a co2 bypass attachment, which has just been made available. The absorber canister slides into the attachment and becomes engaged by closing the unit. All three ports on the can-can have been sized identically to the ge multi absorber as this is necessary to allow the product to function correctly with the aisys machine. The inside diameter of the water trap portion of the can-can is identical to the ge multi absorber and has been designed to compress the small o-ring on the aisys machine. The rubber sealing surface is highly compressible and the fact that the complainant has noted a greater degree of compression of the o-ring when using the can-can demonstrates an improved seal, as a lack of compression of the o-ring would cause the absorber to leak. In answer to the query raised concerning the lugs that hold the canister in place, the can-can lugs that mount onto the metal bar closest to the port carrying expired co2 (the expiratory port) on the aisys machine are identical in length to the ge multi absorber. The other two lugs engage with the sprung clip on the machine and are 2mm shorter on the can-can than on the multi absorber. This difference in length has no bearing on the security of the attachment of the can-can to the aisys machine and the only causes of a canister "popping off" the machine would be failure of the sprung clip attachment on the aisys machine or improper engagement of the canister. Once the canister is correctly engaged the only way to remove it from the machine is to activate the release clip. The several cases of canister "popping off" the machine mentioned by mr fechter have not been reported to armstrong medical and, prior to the receipt of the medwatch form, the only report on the use of the product we received from the hosp was of problems with the performance of the aisys machine. We understand that these problems were not related to the absorber and ge responded by suggesting, via their sales rep, that the can-can not be used for a trial period to see if performance improved. This trial period has now ended and we understand that problems still exist despite the exclusive use of the ge multi absorber. It is worth pointing out that there is a distinct similarity between the language used to describe the nature of the problem with the can-can on the medwatch form and that used by a ge sales rep in an email from an end-user at the same hosp to us. It was also suggested that the increased diameter of the can-can may cause problems with the engagement of the canister on the aisys machine. When properly aligned and engaged the can-can is close to the aisys machine but does not touch any part of it. Indeed, the close proximity of the can-can to the machine can act as a visual aid to the end-user to allow verification of the correct alignment of the canister on the machine. The larger diameter of the can-can allows improved gas to granule contact and airflow dynanics as demonstrated by the quality of the colour change. Also, when the can-can is correctly aligned and engaged on the anesthetic machine it does not leak; this is verified by the pressure test carried out during machine setup. Leaks which cause the pressure test to fail may originate from any part of the anaesthetic circuit and all components should be checked carefully, not just the absorber canister.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616692-2006-00001 |
| MDR Report Key | 965067 |
| Report Source | 00,06 |
| Date Received | 2006-09-01 |
| Date of Report | 2006-08-31 |
| Date of Event | 2006-06-29 |
| Date Mfgr Received | 2006-07-18 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2007-12-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | WATTSTOWN BUSINESS PARK NEWBRIDGE RD |
| Manufacturer City | COLERAINE BT521BS |
| Manufacturer Country | EI |
| Manufacturer Postal | BT52 1BS |
| Manufacturer Phone | 4287035602 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMSORB PLUS CAN-CAN |
| Generic Name | CARBON DIOXIDE ABSORBER |
| Product Code | CBL |
| Date Received | 2006-09-01 |
| Model Number | AMAB3800 |
| Catalog Number | AMAB3800 |
| Lot Number | 100406F31 |
| ID Number | * |
| Device Expiration Date | 2008-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 721600 |
| Manufacturer | ARMSTRONG MEDICAL LTD. |
| Manufacturer Address | * COLERAINE, COUNTY LONDONDERRY * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-01 |