FDA Adverse Event Injury Summary report: N

PLASMAPHERESIS

MDR report key: 10945637 · Received December 3, 2020

Report

Report Number
MW5098191
Event Type
Injury
Date Received
December 3, 2020
Manufacturer
UNK
Product Code
LKN
Adverse Event
Yes
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. THERAPY IN CASE 5 CONTINUED IN THE ICU AFTER 5 CYCLES OF PLASMAPHERESIS FOR REACTIVATION OF CYTOMEGALOVIRUS INFECTION. HOW DIAGNOSIS WAS MADE: CLINICAL ASSESSMENT; IMAGING; PCR. WHY INFECTION IS DIFFICULT TO TREAT? THERE IS NO STANDARD/APPROVED THERAPY FOR THIS DISEASE; UNUSUAL DISEASE PRESENTATION. 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. ABSTRACT: 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).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1408033 PLASMAPHERESIS SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN UNK

Patients

Seq Age Sex Outcome Treatment
1 Other