MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-30 for CRIT LINE BLOOD CHAMBER * manufactured by In-line Diagnostics.
[187828]
Apparent defect in crit-line chamber on dialysis blood line allowed blood to leak out. Discovered during treatment & changed. 20-30cc blood loss resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 294732 |
| MDR Report Key | 294732 |
| Date Received | 2000-08-30 |
| Date of Report | 2000-08-30 |
| Date of Event | 2000-08-29 |
| Date Facility Aware | 2000-08-29 |
| Report Date | 2000-08-30 |
| Date Added to Maude | 2000-09-11 |
| 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 | CRIT LINE BLOOD CHAMBER |
| Generic Name | HEMATOCRIT MONITORING DEVICE |
| Product Code | JPI |
| Date Received | 2000-08-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 00801 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 285268 |
| Manufacturer | IN-LINE DIAGNOSTICS |
| Manufacturer Address | * KAYSVILLE UT 84037 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-08-30 |