FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Feb 1, 2007 · Event occurred Dec 31, 2006
Report 2937457-2007-00003 · MDR key 812528
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
Patient
83 YR
- Eye Injury
- Therapy/non-surgical treatment, additional
- Chemical Exposure
- Treatment with medication(s)
- Hospitalization required
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT A PT WAS SPRAYED WITH FORMALDEHYDE IN THE EYES DURING MACHINE SET UP. THE TECHNICIAN ATTACHED THE BLUE HANSEN CONNECTOR TO THE DIALYZER. WHEN SHE REMOVED THE DIALYZER PORT CAP TO-ATTACH THE RED HANSEN CONNECTOR, FORMALDEHYDE SPRAYED FROM THE DIALYZER PORT ONTO THE PT WHO WAS SEATED NEXT TO THE MACHINE. THE TECHNICIAN REPORTED THAT THE MACHINE DID NOT GO INTO BYPASS WHEN THE SHUNT DOOR WAS OPENED. THE PT'S EYES WERE FLUSHED WITH 1.5 LITERS OF SALINE. PT WAS THEN TAKEN TO THE HOSPITAL ER WHERE HE RECEIVED FURTHER EYE FLUSHES AND WAS PRESCRIBED EYE DROPS.