FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Mar 22, 2002 · Event occurred Feb 18, 2002
Report 2937457-2002-00023 · MDR key 383998
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
26 YR
- Chest Pain
- Dehydration
- Low Blood Pressure/ Hypotension
- Vomiting
- Hospitalization required
Narrative
Description of Event or Problem
THIS IS A SUPPLEMENTAL REPORT TO A PREVIOUSLY SUBMITTED MEDWATCH. INITIAL REPORT STATED FIVE PTS WERE TAKEN TO THE HOSP. INFO RECEIVED TODAY INDICATES THAT THERE WERE FOUR HOSP ADMISSIONS (THREE PTS) FOR POSSIBLE ULTRAFILTRAION (UF) PROBLEMS. ONE PT WAS ADMITTED TWICE. ONE PT C/O CHEST PAIN AND BECAME HYPOTENSIVE DURING HEMODIALYSIS TREATMENT. HE WAS GIVEN 1,500 CC. OF SALINE AND WAS TAKEN TO THE ER VIA AMBULANCE. HE WAS WEIGHED UPON ADMISSION AND HIS WEIGHT SHOWED THAT HE WAS 2 KG. BELOW HIS DRY WEIGHT OF 26.4 KG.
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT FIVE PTS WERE TAKEN TO THE HOSP FOR VOMITING, CHEST PAINS, HYPOTENSION AND DEHYDRATION. IT IS BELIEVED THAT THESE SYMPTOMS WERE RELATED TO EXCESSIVE FLUID REMOVED DURING HEMODIALYSIS TREATMENTS. IT WAS REPORTED THAT THE PTS LOST 1-2KG. MORE THAN DESIRED.