COBE/SPECTRA
Received Jul 2, 2014 · Event occurred May 9, 2014
Report 3959521 · MDR key 3959521
Device
Generic name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Manufacturer
Terumo Bct, Inc.Model number
*Catalog number
*
Lot number
*
Product problems
- Excess Flow or Over-Infusion
Patient
36 YR
- Overdose
Narrative
Description of Event or Problem
DOING A PLASMA EXCHANGE WITH A COBE SPECTRA. THE MACHINE MALFUNCTIONEDAND GAVE THE PATIENT A BOLUS OF ACDA. IT WAS A FAILURE OF THE ACDA PUMP THAT CAUSED THE PATIENT TO RECEIVE TOO MUCH ACDA.MANUFACTURER RESPONSE FOR DIALYSIS, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================AFTER COMPLETING THE INTERROGATION ON THE SYSTEM, BELOW ARE OUR FINDINGS:THE FAILURE OF THE ENCODER IN THE ANTICOAGULANT (AC) PUMP MOTOR CAUSING THE MOTOR TO GO INTO RUN AWAY MODE GIVING A F20 ERROR CODE WAS THE ONLY REASON FOR THE FAILURE. AS PRECAUTIONS THE AC, PLASMA PUMP MOTORS, PUMP DRIVER BOARD, HALL EFFECTS SWITCH, R.A.M BATTERIES WERE REPLACED AND FULL PM WAS PERFORMED TO INSURE PROPER PERFORMANCE. UNIT RAN FOR ONE HOUR WITH ALL FOUR MOTORS AT 200RPMS NO ERRORS OCCURRED.