MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-02-20 for FRESENIUS USA manufactured by Fresenius Usa.
[17467206]
As patient was being reinfused from hemodialysis machine, a cloud of smoke was seen from behind machine. Dialysis immediately stopped and approximately 200cc of blood remained in tubing. Machine removed from service-checked by biomedical - company notified and new electrical panel ordered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010046 |
| MDR Report Key | 1323510 |
| Date Received | 2009-02-20 |
| Date of Report | 2009-02-20 |
| Date of Event | 2009-02-18 |
| Date Added to Maude | 2009-03-03 |
| 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 |
| Brand Name | FRESENIUS USA |
| Generic Name | DAILYSIS MACHINE |
| Product Code | FKP |
| Date Received | 2009-02-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS USA |
| Manufacturer Address | 95 HAYDEN AVE WALNUT CREEK CA 94598 US 94598 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-02-20 |