NEPHRETECT
Received Aug 30, 1996 · Event occurred Aug 28, 1996
Report 1221361-1996-00001 · MDR key 40919
Device
Generic name
Formaldehyde Detector
Manufacturer
Alden Scientific, Inc.Model number
NACatalog number
5000
Lot number
06728
Patient
UNKNOWN
Narrative
Description of Event or Problem
PT WAS PREPARED FOR DIALYSIS AND AT THE ONSET OF DIALYSIS EXPERIENCED A REACTION, AND DIALYSIS WAS DISCONTINUED. TYPICAL SYMPTOMS OF REBOUND SYNDROME OCCURRED WITH A DROP IN BLOOD PRESSURE, DIZZINESS, AND PT LAPSED INTO A SEMI-CONSCIOUS STATE. BENADRYL WAS ADMINISTERED AND WITHIN 4-5 MINUTES, SYMPTOMS HAD SUBSIDED, BUT PT WAS ADMITTED INTO HOSP FOR OBSERVATION. NO FURTHER DEVELOPMENTS OCCURRED. IN DISCUSSING THE INCIDENT WITH THE CHIEF TECHNICIAN IT WAS BELIEVED THAT THE RINSING PROCEDURE WAS NOT FULLY FOLLOWED. CHIEF TECHNICIAN TESTED THE LOT TO DETERMINE ITS EFFICACY AND IT PROVED TO BE WITHIN SPECS. CO WILL TEST SEVERAL AMPULES FROM THE EFFECTED LOT AND SUBMIT THE RESULTS.
Remedial action
- Other