FDA Adverse Event
Summary report: N
SYSTEM ONE
MDR report key: 1013009
·
Received March 6, 2008
Report
- Report Number
- 1013009
- Date Received
- March 6, 2008
- Date of Event
- September 27, 2007
- Report Date
- March 6, 2008
- Manufacturer
- NXSTAGE MEDICAL, INC.
- Product Code
- KDI
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE DIALYSIS MACHINE ALARMED INDICATING AN OVERHEATED DIALYSATE ERROR. ALARM WOULD NOT CLEAR; TREATMENT TERMINATED. THE BIOMEDICAL TESTING CONCLUDED THAT THE DIALYSATE FLUID WAS TOO HOT AND CAUSED THE MACHINE TO ALARM. THE ALARM THAT WOULD NOT CLEAR MAY HAVE BEEN DUE TO THE WARM ROOM TEMPERATURE COMBINED WITH THE EFFECT OF A NEARBY HEATING LAMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM ONE | HEMODIALYSIS MACHINE | KDI | NXSTAGE MEDICAL, INC. | SYSTEM ONE | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR |