InjuryHZT
NEPHRETECT
Received May 17, 2001 · Event occurred Apr 18, 2001
Report 1221361-2001-00002 · MDR key 333857
Device
Generic name
Formaldehyde Test Reagent
Manufacturer
Alden, A Div Of Metrex Research CorpModel number
UNKCatalog number
5000
Lot number
00117
Product problems
- Reaction
Patient
UNKNOWN
- Swelling
- Breathing difficulties
- Therapy/non-surgical treatment, aborted/stopped
- Therapy/non-surgical treatment, additional
- Chemical Exposure
Narrative
Description of Event or Problem
A HEALTHCARE WORKER FROM THE KIDNEY CENTER REPORTED THAT WHILE 2 PTS WERE HOOKED UP TO DIALYSIS TREATMENT, THEY SIMULTANEOUSLY EXPERIENCED SYMPTOMS OF FORMALDEHYDE EXPOSURE (IE, SWOLLEN LIPS, DIFFICULTY BREATHING). THE DIALYSIS TREATMENTS WERE IMMEDIATELY DISCONTINUED AND THE PTS RECEIVED MEDICAL TREATMENT FROM THE NURSES ON-SITE. THE HEALTHCARE WORKER STATED THAT PRIOR TO TURNING ON THE DIALYSIS MACHINES, NEPHRETECT WAS USED TO DETECT FORMALDEHYDE RESIDUAL. NO RESIDUAL WAS NOTED.