FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Jan 11, 2002 · Event occurred Nov 7, 2001
Report 2937457-2002-00002 · MDR key 371685
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Display or Visual Feedback Problem
- Increase in Pressure
- Insufficient Flow or Under Infusion
Patient
UNKNOWN
- Low Blood Pressure/ Hypotension
- Convulsion
- Blood pressure, low
Narrative
Description of Event or Problem
THE SECOND PATIENT HAD A LOW BLOOD PRESSURE ONE HOUR AND 15 MINUTES INTO THE TREATMENT. ULTRA-FILTRATE REMOVED WAS 3.4 KG AND THE MACHINE SHOWED THAT 1,270 ML WAS REMOVED. A HIGH VENOUS PRESSURE ALARM WAS REPORTED. PRESSURE HOLDING TEST WAS PERFORMED AND PASSED. NO OTHER TREATMENT PARAMETERS WERE PROVIDED.
Description of Event or Problem
REPORTS OF ULTRA-FILTRATION PROBLEMS THAT WERE OBSERVED OVER SEVERAL MONTHS WERE RECEIVED FROM THE MANUFACTURER'S AFFILIATE IN CANADA ON 12/2001. REPORTS SUGGEST EXCESS FLUID WAS REMOVED DURING HEMODIALYSIS TREATMENTS. INFORMATION PROVIDED WAS VERY LIMITED. THERE WAS NO REPORTED SERIOUS INJURY. THE FIRST PATIENT HAD LOW BLOOD PRESSURE AND CONVULSIONS AFTER ONE HOUR. REPORTED ULTRA-FILTRATE REMOVED WAS 5.5 KG IN ONE HOUR. THE MACHINE SHOWED THAT 1 KG WAS REMOVED. IT WAS UNKNOWN IF THE PRESSURE HOLDING TEST WAS PERFORMED PRIOR TO INITIATING TREATMENT. ON-LINE PRESSURE HOLDING TEST WAS NOT ACTIVATED.