InjuryFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received May 14, 2003 · Event occurred Apr 18, 2003
Report 2937457-2003-00013 · MDR key 460527
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care North AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Air Leak
- Device Alarm System
- Bubble(s)
Patient
72 YR
- Dyspnea
- Low Blood Pressure/ Hypotension
- Other (for use when an appropriate patient code cannot be identified)
- Therapy/non-surgical treatment, additional
- Hospitalization required
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT THE PT COMPLAINED OF SHORTNESS OF BREATH AND BECAME HYPOTENSIVE DURING TREATMENT. AIR WAS NOTICED IN THE VENOUS DRIP CHAMBER AND THE VENOUS LINE. THERE WAS A FLUID LEVEL BUT THERE WAS ALSO AIR AND BUBBLES IN THE VENOUS CHAMBER. THERE WAS NO AIR NOTED IN THE ARTERIAL LINE OR THE VENOUS LINE PRE DRIP CHAMBER. THE PT WAS TAKEN TO THE HOSPITAL WITH AN ADMITTING DIAGNOSIS OF DYSPNEA. THE PT HAS BEEN DISCHARGED FROM THE HOSPITAL. NO DISCHARGE DIAGNOSIS IS AVAILABLE.