FDA Adverse Event
Malfunction
Summary report: N
NXSTAGE SYSTEM ONE
MDR report key: 1589652
·
Received January 20, 2010
Report
- Report Number
- 3003464075-2010-00007
- Event Type
- Malfunction
- Date Received
- January 20, 2010
- Date of Event
- December 23, 2009
- Report Date
- December 23, 2009
- Manufacturer
- NXSTAGE MEDICAL, INC.
- Product Code
- KDI
- PMA / PMN Number
- K050525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DISPOSABLE CARTRIDGE WAS NOT RETURNED FOR EVAL AS REQUESTED. THE REPORTED EVENT CANNOT BE CONFIRMED. THE USER'S GUIDE CONTAINS PROBABLE CAUSES FOR ALARMS AND ADEQUATE INSTRUCTIONS FOR ALARM RECOVERY. A REVIEW OF THE REPORTED LOT NUMBER FOUND NO OTHER SIMILAR COMPLAINTS REPORTED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.
Description of Event or Problem · 1
A VENOUS PRESSURE LOW ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR NOTED BLOOD LEAKING WHERE THE ARTERIAL BLOOD TUBING CONNECTS TO THE DIALYZER AND IMMEDIATELY ENDED TREATMENT WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. NO 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 | 9107715 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR |