inforMED
OtherHZT

NEPHRETECT

Received Aug 30, 1996 · Event occurred Aug 28, 1996

Report 1221361-1996-00001 · MDR key 40919

Device

Generic name

Formaldehyde Detector

Model number

NA

Catalog 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