MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-12 for SODASORB LF UNKNOWN manufactured by W.r. Grace And Company.
[15500469]
Defective soda-lime cannister issue. Received call from anesthesia tech. She said the anesthesiologist was not able to ventilate the patient in or and they had to switch out the anesthesia machine with one from another or. I checked the machine and found one of the soda-lime packs to be the problem, it did not have any holes in the bottom of if to allow flow through it. Aestiva anesthesia machine. Health professional's impression:visually see the holes intended to be on the bottom of the filter had not been cut out of the plastic. Manufacturing flaw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822960 |
| MDR Report Key | 1822960 |
| Date Received | 2010-08-12 |
| Date of Report | 2010-08-12 |
| Date of Event | 2010-08-04 |
| Report Date | 2010-08-12 |
| Date Reported to FDA | 2010-08-12 |
| Date Added to Maude | 2010-09-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SODASORB |
| Generic Name | ABSORBENT, CARBON-DIOXIDE |
| Product Code | CBL |
| Date Received | 2010-08-12 |
| Model Number | LF |
| Catalog Number | UNKNOWN |
| Lot Number | UNK |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.R. GRACE AND COMPANY |
| Manufacturer Address | 7500 GRACE DR. COLUMBIA MD 21044 US 21044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-12 |