FRESENIUS DIALYSIS DELIVERYS SYSTEM
Received Aug 13, 2008 · Event occurred Jul 14, 2008
Report 2937457-2008-00008 · MDR key 1118447
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Device Rinsing Issue
Patient
64 YR
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT A PATIENT C/O FEELING WARM AND FLUSHED A FEW MINUTES AFTER A HEMODIALYSIS TREATMENT WAS INITIATED. HER SYMPTOMS GOT WORSE AND SHE C/O SHORTNESS OF BREATH AS TREATMENT PROGRESSED. THEY TESTED THE DIALYSATE FOR RESIDUAL BLEACH AND IT TESTED NEGATIVE AT THE DRAIN BUT POSITIVE AT THE HANSEN CONNECTOR. TREATMENT WAS TERMINATED, AND SHE WAS TAKEN TO THE HOSPITAL FOR ER. THE FLUID (SALINE AND BLOOD) IN THE EXTRACORPOREAL CIRCUIT WAS BROWNISH IN COLOR.
Additional Manufacturer Narrative
DEVICE INVESTIGATION SHOWED THAT ONE OF THE CONCENTRATE WANDS WAS NOT PROPERLY INSERTED INTO THE RINSE PORT AFTER A CHEMICAL DISINFECTION. RESIDUAL CHEMICAL WAS PROBABLY NOT CLEARED FROM THE TUBING AND THE STAFF FAILED TO TEST THE MACHINE FOR RESIDUAL BLEACH PRIOR TO INITIATING TREATMENT.