MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-10-15 for SODASORB 4-8 IND H MED manufactured by W.r. Grace & Co. - Conn.
[1736532]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8974506]
The device was identified as sodasorb 4-8 ind h med packaged in a pre-pak unit and the bottom grid of the unit was blocked or occluded. At that time we were unable to obtain a batch number from the end user. Upon confirmation, this was indeed (b)(6) product and the unit's grid was blocked or occluded, we stopped shipments of all sodasorb 4-8 ind h med in pre-pak units. We were advised that (b)(6) hospital was not prepared to return the device to (b)(6). As such, (b)(6) traveled to the end-user's location to continue our investigation. During the course of the investigation, we confirmed 99% of openings in the bottom of the pre-pak unit were blocked or occluded due to flash-set of the polymeric resin. It was also noted that the pre-pak unit was not properly stamped with a batch number. The hospital identified the problem during preparation for surgery and replaced the anesthesia unit prior to beginning the procedure resulting in no pt harm. (b)(6) also had the opportunity to visually inspect numerous pre-pak units at the hospital from the same lot. (b)(6) strongly suspects that the defective device in question was manufactured in may 2010, as the products in the hospital's possession had expiration dates of may 2012 (which would indicate manufacture in may 2010). No other pre-pak units with occlusions were found in the hospital's possession. As a result of the finding of occlusion at the user facility, (b)(6) immediately began re-inspection of all sodabsorb 4-8 ind h med pre-pak units in our inventory and made arrangements to re-inspect product manufactured in may of 2010, which was available at our distributor locations. This re-inspection included removal of our protective shrink wrap, visually inspecting both the bottom and upper grids for occlusions and re-testing the unit through the air flow test. On (b)(6) 2010, we completed re-inspection of all sodasorb 4-8 ind h med pre-pak units in our inventory along with (b)(6) 2010 production available at our distributors. The final re-inspection showed: total number of units inspected = 65,340 units. Total number of units with occlusion = 2 units. Of the two pre-pak units found to be occluded or blocked, one was the above-referenced unit found by the end-user at (b)(6) and the other was located in inventory at (b)(6) and had not been shipped. Additionally, (b)(6) began investigation of the mfg process of the unfilled pre-pak unit, which is provided by a sub-supplier. (b)(6) interviewed this supplier and discussed possible causes and corrective actions with its quality, production and engineering managers. As a result of our investigation, we concluded that the most probable reason (b)(6) received blocked or occluded pre-pak unit bodies from the supplier was due to inadequate segregation between parts made during the start-up process and those made after the switch to a production run. We have taken corrective actions to prevent the re-occurrence of this type of device malfunction, both in our facilities' packaging line and in the requirements imposed on our supplier of the pre-pak unit bodies and lids.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003940942-2010-00002 |
| MDR Report Key | 1898899 |
| Report Source | 06 |
| Date Received | 2010-10-15 |
| Date of Report | 2010-10-15 |
| Date of Event | 2010-08-04 |
| Date Mfgr Received | 2010-08-31 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2011-02-22 |
| 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 | 0 |
| 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 STREET |
| 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 | CBL - ABSORBENT CARBON DIOXIDE |
| Product Code | BSF |
| Date Received | 2010-10-15 |
| Lot Number | UNK |
| Device Expiration Date | 2012-05-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.R. GRACE & CO. - CONN |
| Manufacturer Address | CHICAGO IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-15 |