FDA Adverse Event
Malfunction
Summary report: N
PHOENIX
MDR report key: 725897
·
Received May 10, 2006
Report
- Report Number
- 9616240-2006-00336
- Event Type
- Malfunction
- Date Received
- May 10, 2006
- Report Date
- May 10, 2006
- Manufacturer
- GAMBRO DASCO
- Product Code
- FII
- PMA / PMN Number
- K001156
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
NO PATIENT INJURY WAS REPORTED. INVESTIGATION IS ONGOING 510(K)# IS K001156
Description of Event or Problem · 1
THE CUSTOMER REPORTED BLOOD LOSS FOLLOWING A HIGH VENOUS PRESSURE ALARM. THE VENOUS PRESSURE AT A CERTAIN MOMENT WENT VERY HIGH, THE MACHINE WA ALARMING WITH AIR IN BLOOD. BOTH AIR BUBBLE DETECTOR AND DIAPHRAGM NEUTRAL POSITION PROCEDURE WAS PERFORMED. VENOUS PRESSURE DROPPED TO NORMAL, AND THE TREATMENT COULD GO ON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHOENIX | HEMODIALYSIS EQUIPMENT | FII | GAMBRO DASCO | PHOENIX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |