FDA Adverse Event Summary report: N

PLASMAPHERESIS

MDR report key: 10945631 · Received December 3, 2020

Report

Report Number
MW5098190
Date Received
December 3, 2020
Report Date
November 24, 2020
Manufacturer
UNK
Product Code
LKN
Report Source
Voluntary report
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

THE ALBUMIN QUOTIENT WAS ELEVATED IN THREE OF FIVE PATIENTS, AND OGB WAS NEGATIVE IN ALL FIVE. THEREFORE, PLASMAPHERESIS WITH ALBUMIN WAS INITIATED AND PERFORMED ON ALTERNATE DAYS ON THE HYPOTHESIS OF AN AUTOIMMUNE CNS INVOLVEMENT FOR BOTH MRI POSITIVE AND NEGATIVE CASES. DRUGS USED IN NEW WAY: AZITHROMYCIN: TO TREAT A DISEASE OTHER THAN THE ONE FOR WHICH THE DRUG IS APPROVED; IN A NOVEL COMBINATION WITH ANOTHER DRUG HYDROXYCHLOROQUINE: TO TREAT A DISEASE OTHER THAN THE ONE FOR WHICH THE DRUG IS APPROVED; IN A NOVEL COMBINATION WITH ANOTHER DRUG FAVIPIRAVIR: TO TREAT A DISEASE OTHER THAN THE ONE FOR WHICH THE DRUG IS APPROVED; IN A NOVEL COMBINATION WITH ANOTHER DRUG PLASMAPHERESIS: TO TREAT A DISEASE OTHER THAN THE ONE FOR WHICH THE DRUG IS APPROVED; IN A NOVEL COMBINATION WITH ANOTHER DRUG DRUG TREATMENT SETTING: AZITHROMYCIN: ICU/CRITICAL CARE. HYDROXYCHLOROQUINE: ICU/CRITICAL CARE. FAVIPIRAVIR: ICU/CRITICAL CARE. PLASMAPHERESIS: ICU/CRITICAL CARE. SEVERE SARS-COV-2 (COVID-19) INFECTION HAS THE POTENTIAL FOR A HIGH MORTALITY RATE. IN THIS PAPER, WE REPORT THE RESULTS OF PLASMAPHERESIS TREATMENT IN A SERIES OF SEVERELY ILL PATIENTS WITH COVID-19-RELATED AUTOIMMUNE MENINGOENCEPHALITIS IN THE INTENSIVE CARE UNIT (ICU). KEYWORDS: AUTOIMMUNE; COVID-19; ENCEPHALITIS; PLASMAPHERESIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1408032 PLASMAPHERESIS SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN UNK

Patients

Seq Age Sex Outcome Treatment
1 Other