MalfunctionLKN
SPECTRA OPTIA
Received Mar 7, 2014 · Event occurred Jan 31, 2014
Report 3678819 · MDR key 3678819
Device
Generic name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Manufacturer
Terumo Bct, Inc.Model number
*Catalog number
*
Lot number
05V3229
Product problems
- Material Disintegration
Patient
51 YR
- No Code Available
Narrative
Description of Event or Problem
TUBING KIT FOR OPTIA TPE (THERAPEUTIC PLASMA EXCHANGE) MALFUNCTIONED DURING PROCEDURE; LOUD BANG HEARD, WHITE UPPER PLASTIC BRACE HOUSING NOTED TO BE SHREDDED. PROCEDURE ABORTED AND NEW TUBING KIT SET UP. PATIENT DID NOT RECEIVE RINSEBACK; APPROXIMATELY 195 CCS OF WB NOT RETURNED TO PATIENT.