MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-05 for * manufactured by Fresenius Medical Care North America.
[1393596]
Blood pump malfunctioned on hemodialysis machine. An attempt was made to manually return patient's blood without success. No true injury. However, patient did lose approximately 250 cc of blood.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1562362 |
| MDR Report Key | 1562362 |
| Date Received | 2009-12-05 |
| Date of Report | 2009-12-05 |
| Date of Event | 2009-11-25 |
| Report Date | 2009-12-05 |
| Date Reported to FDA | 2009-12-05 |
| Date Added to Maude | 2009-12-21 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | HEMODIALYSIS MACHINE |
| Product Code | FII |
| Date Received | 2009-12-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | 920 WINTER STREET WALTHAM MA 02451145 US 02451 1457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-05 |