InjuryFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Jun 29, 2006 · Event occurred May 26, 2006
Report 2937457-2006-00004 · MDR key 731685
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care North AmericaModel number
2008HCatalog number
NA
Lot number
NA
Product problems
- Alarm, audible
- Output, low
- Decrease in Pressure
Patient
43 YR
- Swelling
- Other (for use when an appropriate patient code cannot be identified)
- Discomfort
- Therapy/non-surgical treatment, aborted/stopped
- Blood pressure, increased
- Hospitalization required
- Weight Changes
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT A PATIENT GAINED WEIGHT DURING A HEMODIALYSIS TREATMENT. THERE WERE REPORTEDLY LOW TMP ALARMS THAT HAD TO BE RESET EVERY 5 MINUTES. ABOUT 3 HRS INTO THE TREATMENT, THE PATIENT C/O DISCOMFORT AND TIGHTNESS IN HER ARMS AND FINGERS. THE STAFF NOTICED THAT HER FACE WAS SWOLLEN. TREATMENT WAS DISCONTINUED. THE PATIENT WAS WEIGHED AND HER POST DIALYSIS WEIGHT INDICATED A WEIGHT GAIN OF 5.7 KG. SHE WAS TAKEN TO THE HOSPITAL, DIALYZED AND DISCHARGED THE NEXT DAY.