MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-21 for 2008K HEMODIALYSIS MACHINCE manufactured by Fresenius Medical Care North America.
[4152933]
Saline bag filled inappropriately while using a fresenius 2008k dialysis machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033115 |
| MDR Report Key | 3492289 |
| Date Received | 2013-11-21 |
| Date of Report | 2013-11-20 |
| Date of Event | 2013-11-20 |
| Date Added to Maude | 2013-11-29 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2008K HEMODIALYSIS MACHINCE |
| Generic Name | 2008K HEMODIALYSIS MACHINE |
| Product Code | FII |
| Date Received | 2013-11-21 |
| Model Number | 2008K |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-21 |