inforMED
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

61000

Patient

31 YR · Female

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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.