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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLASMAPHERESIS; SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
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PLASMAPHERESIS; SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC Back to Search Results
Device Problems Off-Label Use (1494); High Test Results (2457)
Patient Problems Autoimmune Disorder (1732); Encephalitis (2429)
Event Type  No Answer Provided  
Event Description
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.
 
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Brand Name
PLASMAPHERESIS
Type of Device
SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
MDR Report Key10945631
MDR Text Key219919100
Report NumberMW5098190
Device Sequence Number1
Product Code LKN
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/03/2020
Patient Sequence Number1
Patient Outcome(s) Other;
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