BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRISMAFLEX

    MDR report key: 11465648 · Received March 11, 2021

    Report

    Report Number
    9616026-2021-00011
    Event Type
    Death
    Date Received
    March 11, 2021
    Date of Event
    February 12, 2021
    Report Date
    May 20, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K110823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE WAS INSPECTED ON SITE BY A QUALIFIED BAXTER TECHNICIAN. NO WORKING DEVIATION ON THE PRISMAFLEX MACHINE WAS DETECTED DURING THE INSPECTION. THE ARPS TUBING WAS REPORTED TO HAVE BEEN REPLACED. REVIEW OF COMPLAINTS AND SERVICE HISTORY DETERMINED THAT ONE SIMILAR EVENT OCCURRED ON THIS MACHINE. NO DEVIATIONS FROM MANUFACTURER SPECIFICATIONS WAS DETECTED. THE LOX FILES WERE REVIEWED AND THERE WAS NO EVIDENCE OF A CRITICAL CONDITION REQUIRING DISCONTINUATION OF THE TREATMENT AND NO EVIDENCES OF ALARMS TRIGGERED BY THE MACHINE ARE PROVIDED. NO PRISMAFLEX MALFUNCTIONING HAS BEEN IDENTIFIED. BASED ON AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT PRISMAFLEX MACHINE CAUSED OR CONTRIBUTED TO THE SERIOUS EVENT OF PATIENT DEATH. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IT HAS BEEN IDENTIFIED THAT COMPLAINTS (B)(4) AND (B)(4) ARE DUPLICATES THEREFORE NO ADDITIONAL EMDR FOLLOW UP WILL BE SUBMITTED FOR 2925443. ALL THE INFORMATION ASSOCIATED WITH THIS EVENT IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COVID 19 POSITIVE PATIENT PASSED AWAY DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAFLEX CONTROL UNIT. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360049 PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death