MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-04-05 for SODASORB 4-8 IND H MED SI15%4/8HM -14.2MXC 8870 manufactured by Darex Container Products.
[2606799]
User reported by e-mail on (b)(6) 2012 the following: "we recently identified a sodasorb pre-pak canister supplied to our facility that did not have perforations on both ends of the container that normally allow gas to pass through it. This serious malfunction was picked up during the anesthesia machine check. No other problems noted in the remaining batch of the canisters. " a phone conversation revealed that the event occurred in late (b)(6) 2011 or early (b)(6) 2012 during the change out of the sodasorb canister prior to the start of a second procedure. During change out of the sodasorb, resistance to airflow was discovered. When the canister was removed, they discovered both the top and bottom grid was occluded. The canister was removed and the procedure was completed with a new pre-pak canister without incident.
Patient Sequence No: 1, Text Type: D, B5
[9959029]
For informational purposes, the medical device of concern is sodasorb 4-8 ind h med carbon dioxide absorbent. It is used with an anesthesia machine to remove expired co2. This particular packaging configuration consists of a body or cup and a lid sonically sealed to the body, with the sodasorb contained within, collectively known as the pre-pak unit. Both the body and the lid are manufactured from polymeric resin using an injection molding process. The lid and the body have a grid of openings centered in the unit. The lid grid is 3 1/2 inches in diameter, while the body grid is 3 1/6 inches in diameter. The openings in the grid are 0. 055 square inches and there are 8 perforations per inch within the grid. The grid allows the flow of the gas through the breathing circuit. This report is associated with the grid on the body or what is considered the bottom of the pre-pak unit. The original complaint received by (b)(4) ("(b)(4") on (b)(4) 2012, described an event that occurred in late (b)(4) 2011 or early (b)(4) 2012 with sodasorb 4-8 ind h med. The event was reported by doctor (b)(6) medical clinician by e-mail. The facility at which the event took place was the (b)(6) medical center in (b)(6). Upon receipt of the complaint, (b)(4) contacted the user facility to obtain additional info regarding the specific device involved in the event, details relating to the batch number of the material and to request the device be returned to (b)(4). The device was identified as sodasorb 4-8 ind h med packaged in a pre-pak unit and the top and bottom grids of the unit were blocked or occluded. We were advised that the va medical center had disposed of the pre-pak unit and it was not available for a full investigation. Doctor (b)(6) provided 2 photographs which show the blocked or occluded grid. The hospital had identified the problem during preparation for surgery and replaced the occluded pre-pak unit prior to beginning the procedure resulting in no pt harm. During additional conversations with doctor (b)(6), he confirmed that he believed both the top and bottom grids of the pre-pak unit were occluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003940942-2012-00001 |
| MDR Report Key | 2544228 |
| Report Source | 05,06 |
| Date Received | 2012-04-05 |
| Date of Report | 2012-03-29 |
| Date of Event | 2011-12-01 |
| Date Mfgr Received | 2012-03-08 |
| Device Manufacturer Date | 2011-05-01 |
| Date Added to Maude | 2012-09-07 |
| 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 | STEPHANIE WOOD |
| Manufacturer Street | 62 WHITTEMORE AVE |
| Manufacturer City | CAMBRIDGE MA 02140 |
| Manufacturer Country | US |
| Manufacturer Postal | 02140 |
| Manufacturer Phone | 6174984357 |
| Manufacturer G1 | DAREX CONTAINER PRODUCTS |
| Manufacturer Street | 6050 WEST 51ST ST. |
| Manufacturer City | CHICAGO IL 60638 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60638 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SODASORB 4-8 IND H MED |
| Generic Name | CARBON DIOXIDE ABOSRBENT |
| Product Code | BSF |
| Date Received | 2012-04-05 |
| Model Number | SI15%4/8HM -14.2MXC |
| Catalog Number | 8870 |
| Lot Number | CA05-P115-11 |
| Device Expiration Date | 2013-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAREX CONTAINER PRODUCTS |
| Manufacturer Address | CHICAGO IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-05 |