BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 14116662 · Received April 15, 2022

    Report

    Report Number
    3009211636-2022-00092
    Event Type
    Injury
    Date Received
    April 15, 2022
    Date of Event
    December 21, 2020
    Report Date
    April 14, 2022
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: PLASMA EXCHANGE IN REFRACTORY ACUTE DISSEMINATED ENCEPHALOMYELITIS ASSOCIATED WITH COVID-19: TECHNICAL CHALLENGES IN A DEVELOPING COUNTRY SOURCE: © 2021. THIEME. ALL RIGHTS RESERVED. GEORG THIEME VERLAG KG, RÜDIGERSTRASSE 14, 70469 STUTTGART, GERMANY DOI HTTPS://DOI.ORG/ 10.1055/S-0041-1722927. ISSN 1304-2580. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY, A PEDIATRIC PATIENT WITH COVID-19 (CORONAVIRUS DISEASE 2019), SUDDEN-ONSET ASYMMETRIC QUADRIPARESIS, PAINFUL LOSS OF VISION, AND ACUTE DEMYELINATING ENCEPHALOMYELITIS (ADEM) THAT REQUIRED PLASMA EXCHANGE (PEX). AFTER TOLERATING FOUR ALTERNATE-DAY PEX SESSIONS WELL USING 11.5-FR DOUBLE LUMEN TEMPORARY HEMODIALYSIS CATHETER (COVIDIEN) INSERTED IN RIGHT INTERNAL JUGULAR VEIN AND A COMPETITOR HEMODIALYSIS MACHINE, THE PATIENT EXPERIENCED FEVER WITH CHILLS AND WAS STARTED ON IV (INTRAVENOUS) CEFTAZIDIME AND VANCOMYCIN. THE CATHETER WAS REMOVED AND THE CATHETER TIP LATER REVEALED (B)(6) ON CULTURE. THE PATIENT BECAME AFEBRILE IN 2 DAYS AND WAS DISCHARGED FROM THE HOSPITAL ON DAY 29.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140481 DIALYSIS UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female Required Intervention