FDA Adverse Event
Death
Summary report: N
PHOENIX
MDR report key: 743400
·
Received July 31, 2006
Report
- Report Number
- 9616240-2006-00407
- Event Type
- Death
- Date Received
- July 31, 2006
- Date of Event
- April 29, 2005
- Report Date
- May 2, 2005
- Manufacturer
- GAMBRO DASCO
- Product Code
- FII
- PMA / PMN Number
- K001156
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
FOUND A, B AND DIASCAN CONDUCTIVITIES ARE CALIBRATED PROPERLY. FOUND ARTERIAL AND VENOUS PRESSURES, PATIENT SENSOR, AND PATIENT SENSOR LED, TEMPERATURE ARE CALIBRATED PROPERLY. DURING 30 MIN SIMULATED TREATMENT, FOUND AIR IN BLOOD ALARM, ARTERIAL & VENOUS PRESSURES WORKED PROPERLY. FLUID REMOVAL ACCURATE AND CURRENT LEAKAGE AND GROUND INTEGRITY TESTS WITHIN STANDARD. NO CORRECTIVE ACTION FOUND. NO MACHINE MALFUNCTION WAS IDENTIFIED. GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT ITS DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF LIABILITY.
Description of Event or Problem · 1
REQUEST TO CHECK OUT MACHINE AFTER PATIENT CODED DURING TREATMENT, WAS TRANSPORTED TO THE HOSPITAL WHERE PRONOUNCED.
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 | Death |