MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-16 for 2008-K manufactured by Fresenius.
[1645999]
A 24v alarm.... All machine function was lost during treatment.... Had to use manual crank to return pt's blood. Treatment ended per md, and there was no pt blood loss or harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015596 |
| MDR Report Key | 1664420 |
| Date Received | 2010-04-16 |
| Date of Report | 2010-04-16 |
| Date of Event | 2010-04-10 |
| Date Added to Maude | 2010-04-26 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| 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 |
| Generic Name | FRESENIUS DIALYSIS MACHINE |
| Product Code | FII |
| Date Received | 2010-04-16 |
| Model Number | 2008-K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-04-16 |