FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Apr 18, 2002 · Event occurred Feb 8, 2002
Report 2937457-2002-00027 · MDR key 389819
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Underdelivery
Patient
64 YR
- Low Blood Pressure/ Hypotension
- Weakness
- Other (for use when an appropriate patient code cannot be identified)
- Therapy/non-surgical treatment, additional
- Hospitalization required
Narrative
Description of Event or Problem
THESE ARE TWO OF THE EVENTS REPORTED IN A PREVIOUSLY SUBMITTED MEDWATCH REPORT (00023). ADDITIONAL INFORMATION WAS RECEIVED ON 4/2002. THIS PATIENT WAS DIALYZED ON THE SAME MACHINE AND ADMITTED TO THE HOSPITAL TWICE FOR SIMILAR PROBLEMS. AT THE END OF A HEMODIALYSIS TREATMENT, THE PATIENT BECAME HYPOTENSIVE, INCOHERENT, WEAK AND UNABLE TO STAND. PATIENT WAS GIVEN A TOTAL OF 950 CC. OF SALINE. THE MACHINE INDICATED THAT 1,000 ML. WAS REMOVED. PATIENT WAS DISCHARGED HOME BUT WAS LATER TAKEN TO THE HOSPITAL BY THE FAMILY.
Description of Event or Problem
AT THE END OF A HEMODIALYSIS TREATMENT, THE PATIENT BECAME INCOHERENT, WEAK AND SLUGGISH. PATIENT'S BLOOD SUGAR WAS 126. PATIENT WAS GIVEN A TOTAL OF 1,050 CC. OF SALINE. THE MACHINE WAS SET TO REMOVE 300 ML. AND IT INDICATED THAT 300 ML. WAS REMOVED. PATIENT'S PRE WEIGHT WAS 62.9 KG. POST WEIGHT WAS NOT TAKEN SINCE PATIENT WAS TOO WEAK TO STAND. PATIENT WAS TRANSPORTED TO THE HOSPITAL BY EMS. REASON FOR ADMISSION WAS BELIEVED TO BE RELATED TO EXCESSIVE FLUID REMOVED.