InjuryFJG
FILTRAL 20
Received Mar 8, 2000 · Event occurred Feb 4, 2000
Report 8010182-2000-00002 · MDR key 267760
Device
Product problems
- Reaction
- Replace
Patient
15 YR
- Allergic reaction
- Tachycardia
- Anxiety
- Breathing difficulties
- Diaphoresis
- Therapy/non-surgical treatment, additional
- Blood pressure, decreased
Narrative
Description of Event or Problem
APPROXIMATELY 90 SECONDS INTO THE TREATMENT, THE PT COMPLAINED OF SHORTNESS OF BREATH. THE PT WAS NOTED TO BE DIAPHORETIC AND ANXIOUS, WITH A DECREASE IN BLOOD PRESSURE AND AN INCREASE IN PULSE. THE PT WAS SWITCHED TO A POLYFLUX 17S DIALYZER. THE PT REQUIRED OXYGEN AND UNDERWENT TESTING; LAB ANALYSIS WAS POSITIVE FOR ALLERGIC REACTION.
Remedial action
- Other