FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Mar 22, 2002 · Event occurred Feb 23, 2002
Report 2937457-2002-00022 · MDR key 384464
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care North AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Output, high
Patient
UNKNOWN
- Low Blood Pressure/ Hypotension
- Nausea
- Therapy/non-surgical treatment, aborted/stopped
- Treatment with medication(s)
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT THERE WAS EXCESSIVE FLUID REMOVED FROM A PATIENT DURING A HEMODIALYSIS TREATMENT. THE PATIENT BECAME HYPOTENSIVE AND COMPLAINT OF NAUSEA 25 MINUTES INTO THE TREATMENT AND WAS GIVEN 600 ML. OF SALINE. THE PATIENT CONTINUED TO BE SYMPTOMATIC DURING TREATMENT AND ADDITIONAL SALINE WAS GIVEN. TREATMENT WAS DISCONTINUED AFTER AN HOUR AND A HALF. BASED ON THE REPORTED PRE AND POST WEIGHTS, THE PATIENT LOST 3 KG. THE MACHINE INDICATED THAT 769 ML. WAS REMOVED THE PATIENT WAS DISCHARGED IN STABLE CONDITION.