MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06,07 report with the FDA on 2004-05-26 for BARALYME 44-01-0006 manufactured by Allied Healthcare Products, Inc..
[354457]
While a pt was under anesthesia with ulthane (servoflurane) for the insertion of a rigid bronchoscope, the anesthesiologist heard a loud noise described as sounding like a gun shot. The hospital anesthesia team had observed that the rebreathing bag had blown off its attachment on the datex-ohmeda anesthesia machine. The pop-off valve that was partially closed blew off the anesthesia machine and the scavenger hose was blown off its attachment. Flames were present in the lower part of the absorber canister and the loose filled baralyme material appeared to be glowing and flickering. There was the smell of plastic and smoke. The surgeon immediately removed the bronchoscope from the pt and a bag mask unit was attached to the wall outlet and used to ventilate the pt with 100% oxygen. A new anesthesia machine was brought into the operating room and the pt was once again placed under anesthesia with ulthane. The surgeon reinserted the bronchoscope to inspect for injury and no injury was identified. It was determined that the surgical team would continue on to the next phase of the surgical procedure. After continuing to the next phase of surgery (placing of endotracheal tube), the pt developed severe oxygen desaturation and severe bradycardia that required treatment with epinephrine, atropine and chest compressions. The pt recovered after ventilation with 100% oxygen. At this point the procedure was stopped and the pt was moved to the anesthesia recovery unit where the pt successfully recovered from the events. The reporter believed that the events that occurred to the pt were life threatening, though no permanent injury was sustained due to the reported "explosion" of the anesthesia machine. It is believed that the airway difficulties were unrelated to the reported "explosion" of the anesthesia machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1924066-2004-00002 |
| MDR Report Key | 527334 |
| Report Source | 00,05,06,07 |
| Date Received | 2004-05-26 |
| Date of Report | 2004-05-12 |
| Date of Event | 2004-04-27 |
| Date Mfgr Received | 2004-04-27 |
| Date Added to Maude | 2004-06-02 |
| 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 |
| 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 | 2004-05-26 |
| Model Number | 44-01-0006 |
| Catalog Number | 44-01-0006 |
| Lot Number | 11MAR061 |
| ID Number | * |
| Device Expiration Date | 2006-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | 1720 SUBLETTE AVE. ST. LOUIS MO 63110 US 63110 |
| Baseline Brand Name | BARALYME |
| Baseline Generic Name | CARBON DIOXIDE ABSORENT |
| Baseline Model No | 44-01-0006 |
| Baseline Catalog No | 44-01-0006 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2004-05-26 |