FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Oct 23, 2001 · Event occurred Sep 27, 2001
Report 2937457-2001-00026 · MDR key 358915
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care - North AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Increase in Pressure
- Replace
- Underdelivery
Patient
54 YR
- Low Blood Pressure/ Hypotension
- Dizziness
- Other (for use when an appropriate patient code cannot be identified)
- Sweating
- Therapy/non-surgical treatment, additional
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 COMPLAINED OF DIZZINESS 20 MINUTES INTO THE TREATMENT. THE PT ALSO BECAME HYPOTENSIVE AND SWEATY, AND WAS GIVEN 300 ML. OF SALINE. THE MACHINE SHOWED THAT 382 ML. WAS REMOVED. TRANSMEMBRANE PRESSURE INCREASED FROM 46 TO 211. THE MACHINE WAS REPLACED AND TREATMENT WAS COMPLETED WITH THE UF OFF PART OF THE TREATMENT. BASED ON THE PATIENT'S WEIGHTS AND WHAT THE MACHINES INDICATED WAS REMOVED, THERE WAS A WEIGHT LOSS VARIANCE OF APPROXIMATELY 1.4 KG. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.