FDA Adverse Event Death Summary report: N

SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC

MDR report key: 10945616 · Received December 3, 2020

Report

Report Number
MW5098189
Event Type
Death
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. THE CLINICAL PICTURE IN CASE 3 WORSENED, WITH REFRACTORY FEVER AROUND 40.5 ¿C AND FERRITIN LEVELS THAT PEAKED AT 15,669 NG/ML. CARDIAC ARREST DEVELOPED AND CPR WAS UNSUCCESSFUL. THERE IS NO STANDARD/APPROVED THERAPY FOR THIS DISEASE; UNUSUAL DISEASE PRESENTATION. 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). ARTICLE URL: HTTPS://PUBMED.NCBI.NLM.NIH.GOV/32389697/JOURNAL: BRAIN, BEHAVIOR, AND IMMUNITY. PUBLICATION YEAR: 2020; PUBLISHED AUTHORS: DOGAN L, KAYA D, SARIKAYA T, ZENGIN R, DINCER A, AKINCI IO, AFSAR N.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1408031 SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN UNK

Patients

Seq Age Sex Outcome Treatment
1 Death