MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-10-21 for BARALYME 44-01-0005 manufactured by Allied Healthcare Products, Inc..
[293171]
During surgery, baralyme absorbent canister in use with sevoflurane anesthetic gas started to melt and burn. Pt inhaled smoke and hot gases and required further treatment. Baralyme canister in question was installed in anesthesia machine in 2003 and the machine with absorbent canister was used one day later several cases with no problems reported. Hosp claims that the sevoflurane anesthetic gas flow was shut off over the weekend.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1924066-2003-00008 |
| MDR Report Key | 491507 |
| Report Source | 05,06 |
| Date Received | 2003-10-21 |
| Date of Report | 2003-10-20 |
| Date of Event | 2003-10-06 |
| Date Mfgr Received | 2003-10-08 |
| Date Added to Maude | 2003-10-28 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1720 SUBLETTE AVE |
| Manufacturer City | ST. LOUIS MO 63110 |
| Manufacturer Country | US |
| Manufacturer Postal | 63110 |
| Manufacturer Phone | 3147712400 |
| Manufacturer G1 | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Street | KINDERHOOK & NEW STREET |
| Manufacturer City | STUYVESANT FALLS NY 12174 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12174 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARALYME |
| Generic Name | CARBON DIOXIDE ABSORBENT |
| Product Code | CBL |
| Date Received | 2003-10-21 |
| Model Number | 44-01-0005 |
| Catalog Number | 44-01-0005 |
| Lot Number | 25JUL052 |
| ID Number | * |
| Device Expiration Date | 2005-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 480205 |
| Manufacturer | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | 1720 SUBLETTE AVE. ST. LOUIS MO 63110 US |
| Baseline Brand Name | BARALYME |
| Baseline Generic Name | CARBON DIXOIDE ABSORBENT |
| Baseline Model No | 44-01-0005 |
| Baseline Catalog No | 44-01-0005 |
| Baseline Device Family | CARBON DIOXIDE ABSORBENT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2003-10-21 |