MalfunctionLKN
SPECTRA OPTIA
Received Jan 30, 2019 · Event occurred Jan 23, 2019
Report MW5083581 · MDR key 8293710
Device
Generic name
Seperator, Automated, Blood Cell And Plasma Therapeutic
Manufacturer
Terumo Bct, Inc.Lot number
IP04152
Product problems
- Break
Patient
68 YR
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
PATIENT HAD SIGNIFICANT BLOOD LOSS DUE TO EQUIPMENT MALFUNCTION DURING PLASMAPHERESIS POSSIBLY DUE TO BROKEN LINE IN INSIDE MACHINE CENTRIFUGE. THE PATIENT¿S FIBRINOGEN LEVEL DROPPED FROM 170/DL (LOW) TO 72MG/DL (CRITICAL LEVEL) REQUIRING TRANSFUSION WITH FFP AND MEDICATION TO PREVENT HISTORICAL LIFE-THREATENING ALLERGIC RESPONSE TO PLASMA.