InjuryLKN
SPECTRA OPTIA
Received Nov 4, 2024 · Event occurred Sep 27, 2024
Report MW5162142 · MDR key 20610376
Device
Generic name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Manufacturer
Terumo Bct, Inc.Model number
61000Patient
31 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
PATIENT ADMITTED TO CARDIAC CARE UNIT FOR HELLP SYNDROME. PLAN FOR THERAPEUTIC PLASMA EXCHANGE X5 TREATMENTS OVER 7 DAYS. WHEN LOADING PLASMAPHERESIS MACHINE FOR FIRST TREATMENT, THERE WAS A MALFUNCTION OF A SENSOR AND THE TUBING WOULD NOT LOAD. NOTIFIED MANAGER AND MD ON CALL OF ISSUE. BIOMED AND OPTIA REP HELPED WITH TROUBLESHOOTING, BUT MACHINE CONTINUED TO MALFUNCTION. URGENT TRANSFER ORDERS WERE PLACED FOR APHERESIS TREATMENT. PATIENT TREATED WITH 1000MG SOLUMEDROL AND 2 L FRESH FROZEN PLASMA PRIOR TO TRANSFER.