InjuryLKN
SPECTRA OPTIA EXCHANGE SET
Received May 13, 2019 · Event occurred Apr 26, 2019
Report MW5086607 · MDR key 8608260
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
17 YR
- Chest Pain
- Chest Tightness/Pressure
- Chest Pain
- Chest Tightness/Pressure
Narrative
Description of Event or Problem
PT IS A SICKLE-CELL DISEASE PT UNDERGOING DEPLETION RED BLOOD CELL EXCHANGE; 14 MINS INTO THE DEPLETION PHASE, THE PT EXPERIENCED CHEST TIGHTNESS AND / OR CHEST PAIN AND COUGH. HIS SYMPTOMS RESOLVED WITH SUPPLEMENTAL OXYGEN AND EPINEPHRINE. FDA SAFETY REPORT ID# (B)(4).