MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1997-03-19 for LUNDIA ALPHA ALPHA 700 HG N01849004 manufactured by Gambro Healthcare.
[52510]
An external blood leak was found during dialysis treatment. There was no pt injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030992-1997-00001 |
| MDR Report Key | 77625 |
| Report Source | 06,07 |
| Date Received | 1997-03-19 |
| Date of Report | 1997-02-20 |
| Date of Event | 1997-01-31 |
| Date Mfgr Received | 1997-02-20 |
| Date Added to Maude | 1997-03-24 |
| 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 |
| Generic Name | PLATE DIALYZER |
| Product Code | FJG |
| Date Received | 1997-03-19 |
| Model Number | ALPHA 700 HG |
| Catalog Number | N01849004 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 77288 |
| Manufacturer | GAMBRO HEALTHCARE |
| Manufacturer Address | 1185 OAK ST. LAKEWOOD CO 80215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-19 |