MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-13 for VIA LVM BLOOD GAS AND CHEMISTRY MONITOR LVM 1 * manufactured by Via Medical A Division Of International Biomedical Inc.
[374643]
A via low volume mode monitor designed to provide bedside monitoring of blood gases, electrolytes and hematocrit automatically, was used on a patient. After running several via gasses the nurse noticed the potassium values dropping. The staff immediately ran a rt, respiratory therapy, blood gas to make sure the via was correct. The via co2 was 11 lower than the rt co2. The monitor never indicated that anything was wrong. Based on those inaccurate readings the dr. Had ordered 2 doses of sodium bicarbonate and made changes to the ventilator. The sensor was suspected to be faulty. All remaining sensors from this lot were returned to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 562243 |
| MDR Report Key | 562243 |
| Date Received | 2004-12-13 |
| Date of Report | 2004-12-13 |
| Date of Event | 2004-11-28 |
| Report Date | 2004-12-13 |
| Date Reported to FDA | 2004-12-13 |
| Date Added to Maude | 2005-01-03 |
| 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 | VIA LVM BLOOD GAS AND CHEMISTRY MONITOR |
| Generic Name | LOW VOLUME MODE MONITOR |
| Product Code | CCL |
| Date Received | 2004-12-13 |
| Model Number | LVM 1 |
| Catalog Number | * |
| Lot Number | 0301990263 ( LOT FOR SENSOR) |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 551956 |
| Manufacturer | VIA MEDICAL A DIVISION OF INTERNATIONAL BIOMEDICAL INC |
| Manufacturer Address | 8508 CROSS PARK DRIVE AUSTIN TX 78754 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-12-13 |