MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 1996-12-10 for LUNDIA ALPHA 700 N01849004 manufactured by Gambro Healthcare.
[17170260]
During a dialysis treatment, there was an external blood leak at the sealing plug on the arterial side, above the label. There was no pt injury or medical intervention. The leak clotted off and treatment resumed. Blood loss was estimated to be approx 3cc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030992-1996-00011 |
| MDR Report Key | 55021 |
| Report Source | 01,05,06,07 |
| Date Received | 1996-12-10 |
| Date of Report | 1996-12-10 |
| Report Date | 1996-12-10 |
| Date Mfgr Received | 1996-12-02 |
| Date Added to Maude | 1996-12-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUNDIA ALPHA 700 |
| Generic Name | PLATE DIALYZER |
| Product Code | FJG |
| Date Received | 1996-12-10 |
| Model Number | ALPHA 700 |
| Catalog Number | N01849004 |
| Lot Number | 6-0118-L01 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 55567 |
| Manufacturer | GAMBRO HEALTHCARE |
| Manufacturer Address | 1185 OAK ST LAKEWOOD CO 80215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-12-10 |