FDA Adverse Event
Injury
Summary report: N
NXSTAGE SYSTEM ONE
MDR report key: 1951886
·
Received December 29, 2010
Report
- Report Number
- 3003464075-2010-00150
- Event Type
- Injury
- Date Received
- December 29, 2010
- Date of Event
- December 4, 2010
- Report Date
- December 4, 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 IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK AS DIRECTED IN THE USER'S GUIDE, WHICH INSTRUCTS THE OPERATOR TO PROMPTLY RINSEBACK THE PT'S BLOOD IN THE EVENT OF AN UNRECOVERABLE ALARM. FACILITY STAFF HAS BEEN NOTIFIED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.
Description of Event or Problem · 1
A SYSTEM ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT WHICH COULD NOT BE RESOLVED BY THE OPERATOR. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |