MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-01 for BAXTER CT190 * manufactured by Baxter Healthcare Corp.
[174564]
Major blood leak. Use #12 rep #15 2/22/99 39. 3% hct. Pt complained of headache, blood pressure stable at 136/84, temperature increased 2. 0 degrees 96. 5 - 98. 5. Machine alarmed "blood leak. " hemastix result = "moderate" (++).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 211970 |
| MDR Report Key | 211970 |
| Date Received | 1999-03-01 |
| Date of Report | 1999-03-01 |
| Date of Event | 1999-03-01 |
| Date Facility Aware | 1999-03-01 |
| Report Date | 1999-03-01 |
| Date Reported to FDA | 1999-03-01 |
| Date Added to Maude | 1999-03-03 |
| 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 | BAXTER |
| Generic Name | DIALYZER |
| Product Code | FJT |
| Date Received | 1999-03-01 |
| Model Number | CT190 |
| Catalog Number | * |
| Lot Number | C98H24X |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 205701 |
| Manufacturer | BAXTER HEALTHCARE CORP |
| Manufacturer Address | * DEERFIELD IL 60015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-03-01 |