MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-19 for GALVANIC OXYGEN CELL VTI-102 103102 manufactured by Vascular Technology.
[18915737]
Pt on cardiopulmonary support (open heart surgery). At initiation of cpb the arterial line was dark and the oxygen saturation was dropping. The extracorporeal circuit was checked to identify problem. Oxygen analyzer fuel cell (oxygen line) showing 90% oxygen, no apparent problem, oxygen saturation decreasing, cardiopulmonary support was interrupted. Oxygenator was changed assuming the gas transfer was defective. Pt in good condition during interruption. Pt back in cpb, backup oxygen tank was connected directly to the oxygenator bypassing the fuel cell, oxygenation problem was resolved. The oxygen analyzer fuel cell was checked and a crack was found, the crack allowed oxygen to leak to air before entering the oxygenator. Pt was weaned from cpb with no problems and is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 497518 |
| MDR Report Key | 497518 |
| Date Received | 2003-11-19 |
| Date of Report | 2003-10-21 |
| Date of Event | 2003-10-13 |
| Date Facility Aware | 2003-10-13 |
| Report Date | 2003-10-21 |
| Date Reported to Mfgr | 2003-10-21 |
| Date Added to Maude | 2003-11-26 |
| 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 | 3 |
| 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 | GALVANIC OXYGEN CELL |
| Generic Name | FUEL CELL |
| Product Code | CCL |
| Date Received | 2003-11-19 |
| Returned To Mfg | 2003-10-17 |
| Model Number | VTI-102 |
| Catalog Number | 103102 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 486273 |
| Manufacturer | VASCULAR TECHNOLOGY |
| Manufacturer Address | 175 CABOT STREET LOWELL MA 01854 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-11-19 |