FDA Adverse Event
Injury
Summary report: N
NXSTAGE SYSTEM ONE
MDR report key: 1951897
·
Received December 29, 2010
Report
- Report Number
- 3003464075-2010-00148
- Event Type
- Injury
- Date Received
- December 29, 2010
- Date of Event
- November 28, 2010
- Report Date
- November 28, 2010
- Manufacturer
- NXSTAGE MEDICAL, INC.
- Product Code
- KDI
- PMA / PMN Number
- K050525
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED BLOOD LOSS EVENTS ARE ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK DUE TO AIR IN CIRCUIT, OR POSSIBLE CLOTTING OF THE EXTRACORPOREAL CIRCUIT. THE USER'S GUIDE CONTAINS ADEQUATE INFORMATION REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. FACILITY STAFF HAS BEEN NOTIFIED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.
Description of Event or Problem · 1
THE PT REPORTED ALARMS OCCURRING DURING THREE SEPARATE ROUTINE HEMODIALYSIS TREATMENTS. THE OPERATOR ENDED ALL TREATMENTS WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED COMBINED BLOOD LOSS OF 430CC. THE PT'S STANDARD EPOGEN DOSE WAS INCREASED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NXSTAGE SYSTEM ONE | HIGH PERMEABILITY HEMODIALYSIS SYSTEM | KDI | NXSTAGE MEDICAL, INC. | CAR-170-B | 0097709 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |