MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-01-31 for IS CAN SPHERASORB C02 ABSORBENT CANISTER 2196 manufactured by Intersurgical, Inc..
[1929627]
During the pre-use check of the absorber on the anesthesia machine, it was discovered that granules were exiting the expiratory port on the absorber and entering the breathing circuit. This incident did not occur during patient use but the risk is for the patient to inhale the absorbent granules. This applies only to the ge-adu and anmedic q systems anesthesia machines. The facility where this occurred is using a breathing filter in the breathing circuit that would prevent the granules from being inhaled by the patient.
Patient Sequence No: 1, Text Type: D, B5
[9096723]
Evaluation summary: based on the product complaint and evaluation of the absorber, the product is being recalled. Product that will be recalled will be relabeled with warnings not to use on the ge-adu and anmedic anesthesia machines. During shipping it was discovered that the granules will compress the pad and escape into the water trap and potentially into the inspiratory limb of a breathing circuit. Is cans to be manufactured with two foam pads instead of one in the bottom of the can. A screen will also be added to the bottom of the is can by the water trap to further prevent the granules from escaping. This will allow the absorber to be used on the ge-adu and anmedic anesthesia machines.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319447-2011-00001 |
| MDR Report Key | 1996335 |
| Report Source | 01,06 |
| Date Received | 2011-01-31 |
| Date of Report | 2011-01-31 |
| Date of Event | 2011-01-12 |
| Date Mfgr Received | 2011-01-13 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2012-02-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL ZALEWSKI |
| Manufacturer Street | 417 ELECTRONICS PKWY. |
| Manufacturer City | LIVERPOOL NY 13088 |
| Manufacturer Country | US |
| Manufacturer Postal | 13088 |
| Manufacturer Phone | 3154512900 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IS CAN SPHERASORB C02 ABSORBENT CANISTER |
| Generic Name | ABSORBENT CANISTER |
| Product Code | CBL |
| Date Received | 2011-01-31 |
| Returned To Mfg | 2011-01-19 |
| Model Number | 2196 |
| Lot Number | 1101426 |
| Device Expiration Date | 2013-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERSURGICAL, INC. |
| Manufacturer Address | 417 ELECTRONICS PKWY. LIVERPOOL NY 13088 US 13088 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-01-31 |