FDA Adverse Event
Injury
Summary report: N
NXSTAGE SYSTEM ONE
MDR report key: 1951898
·
Received December 29, 2010
Report
- Report Number
- 3003464075-2010-00149
- Event Type
- Injury
- Date Received
- December 29, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 1, 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
THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK AFTER DIALYSATE WAS DEPLETED DURING TREATMENT. FACILITY STAFF HAS BEEN NOTIFIED. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.
Description of Event or Problem · 1
DIALYSATE DEPLETED PRIOR TO COMPLETION OF A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR DISCONTINUED TREATMENT 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 | 0097705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |