MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-29 for GAMBRO manufactured by Gambro Americas Headquarters.
[1809763]
Machine went into error 40 concentrate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018406 |
| MDR Report Key | 1916843 |
| Date Received | 2010-11-29 |
| Date of Report | 2010-11-29 |
| Date of Event | 2010-05-26 |
| Date Added to Maude | 2010-12-10 |
| 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 |
| 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 | GAMBRO |
| Generic Name | PHOENIX DIALYSIS MACHINE |
| Product Code | FII |
| Date Received | 2010-11-29 |
| Lot Number | GE #35804849 |
| ID Number | PH13644 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO AMERICAS HEADQUARTERS |
| Manufacturer Address | 14143 DENVER WEST PKWY LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-29 |