InjuryLKN
SPECTRA OPTIA EXCHANGE SET
Received May 13, 2019 · Event occurred May 8, 2019
Report MW5086595 · MDR key 8608017
Device
Generic name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Manufacturer
Terumo Bct, Inc.Model number
190403330Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
37 YR
- Hypoxia
- Pain
- Chest Tightness/Pressure
- Hypoxia
- Pain
- Chest Tightness/Pressure
Narrative
Description of Event or Problem
PT IS A SICKLE-CELL DISEASE PT UNDERGOING DEPLETION RED BLOOD CELL EXCHANGE; 12 MINS INTO THE DEPLETION PHASE, THE PT EXPERIENCED A FEELING OF "WATER IN HIS EARS", CHEST TIGHTNESS, COUGH, PAIN, AND HYPOXEMIA WITH OXYGEN SATURATIONS IN THE MID-80S. HIS SYMPTOMS RESOLVED WITH 40MG IV PEPCID AND 4L OXYGEN VIA NASAL CANNULA. FDA SAFETY REPORT ID# (B)(4).