BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 12475963 · Received September 15, 2021

    Report

    Report Number
    3009211636-2021-00256
    Event Type
    Death
    Date Received
    September 15, 2021
    Date of Event
    October 26, 2020
    Report Date
    September 15, 2021
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: PROLONGED INTERMITTENT RENAL REPLACEMENT THERAPY FOR ACUTE KIDNEY INJURY IN COVID-19 PATIENTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME SOURCE: BLOOD PURIFICATION 2021;50:355363. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE CASE STUDY, THIS WAS A SINGLE-CENTER, PROSPECTIVE, OBSERVATIONAL STUDY PERFORMED AT A TERTIARY REFERENCE HOSPITAL DESIGNATED TO TREAT EXCLUSIVELY PATIENTS WITH COVID-19 FROM MARCH 16, 2020 TO JUNE 24, 2020. THE STUDY IDENTIFIED 224 COVID-19 PATIENTS ADMITTED TO THE ICU. 21 (15%) INITIATED PROLONGED INTERMITTENT RENAL REPLACEMENT THERAPY (PIRRT) AND 9 (43%) OF THOSE PATIENTS DIED. NONE OF THE DEATHS WERE DIRECTLY OR INDIRECTLY RELATED TO ADVERSE EVENTS DURING THE PROLONGED INTERMITTENT RENAL REPLACEMENT THERAPY (PIRRT) SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371458 DIALYSIS UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death