MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-03 for AKSYS * manufactured by Aksys Ltd..
[297699]
Pt missed dialysis treatment due to machine being replaced related to "dialysis leak". Pt was able to resume hemo treatments on the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1030466 |
| MDR Report Key | 501760 |
| Date Received | 2003-12-03 |
| Date of Report | 2003-11-20 |
| Date of Event | 2003-11-05 |
| Date Added to Maude | 2003-12-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AKSYS |
| Generic Name | PERSONAL HEMODIALYSIS MACHINE |
| Product Code | KPF |
| Date Received | 2003-12-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 490554 |
| Manufacturer | AKSYS LTD. |
| Manufacturer Address | TWO MARRIOTT DRIVE LINCOLNSHIRE IL 60169 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-12-03 |