FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Mar 9, 2001 · Event occurred Feb 9, 2001
Report 2937457-2001-00004 · MDR key 319854
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Use of Incorrect Control/Treatment Settings
- Display or Visual Feedback Problem
Patient
81 YR
- Low Blood Pressure/ Hypotension
- Nausea
- Vomiting
- Other (for use when an appropriate patient code cannot be identified)
- Hospitalization required
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT THREE PATIENTS COMPLAINED OF NAUSEA, VOMITING AND BECAME HYPOTENSIVE AFTER DIALYZING ON THE SAME MACHINE. THE PATIENTS WERE ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF METABOLIC ACIDOSIS. INITIAL INFORMATION RECEIVED WAS THAT PH AND CONDUCTIVITY WERE REPORTEDLY NORMAL. ADDITIONAL INFORMATION RECEIVED LATER VERIFIED THAT RO WATER PH WAS NORMAL BUT DIALYSATE PH WAS NOT CHECKED. NO MACHINE ALARMS WERE REPORTED FRESENIUS EQUIPMENT SPECIALIST FOUND THE MACHINE WITH INCORRECT SODIUM AND BICARBONATE SETTING. BICARBONATE VALUE WAS UNKNOWN SINCE THE MACHINE SHOWED AN ERRONEOUS DISPLAY. THE PATIENTS WERE IN THE HOSPITAL FOR ABOUT A WEEK AND HAVE BEEN DISCHARGED SINCE.