MAUDE Adverse Event Report: SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Fever (1858); Unspecified Infection (1930)

Event Type  Death  

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.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.

• Brand Name: SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
• MDR Report Key: 10945616
• MDR Text Key: 219880649
• Report Number: MW5098189
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): Y
• Number of Events Reported: 1
• 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

• Date FDA Received: 12/03/2020
• Device Operator: No Information
• Patient Sequence Number: 1
• Patient Outcome(s): Death