FDA Adverse Event
Injury
Summary report: N
NXSTAGE SYSTEM ONE
MDR report key: 1894579
·
Received November 5, 2010
Report
- Report Number
- 3003464075-2010-00107
- Event Type
- Injury
- Date Received
- November 5, 2010
- Date of Event
- October 9, 2010
- Report Date
- October 9, 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 CYCLER ALARMED APPROPRIATELY TO THE AIR IN THE CIRCUIT. THE EXACT CAUSE OF THE AIR ALARM CANNOT BE DETERMINED. THE USER'S GUIDE CONTAINS ADEQUATE INFO REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. NO FURTHER INVESTIGATION IS REQUIRED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.
Description of Event or Problem · 1
AN ARTERIAL AIR ALARM OCCURRED AT THE START OF A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR WAS NOT ABLE TO REMOVE ALL OF THE AIR SUCCESSFULLY. TREATMENT WAS DISCONTINUED W/O PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE PT WAS RESTARTED ON EPOGEN. 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 | 0077719 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |