BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PLEURX

    MDR report key: 16991945 · Received May 24, 2023

    Report

    Report Number
    1625685-2023-00062
    Event Type
    Death
    Date Received
    May 24, 2023
    Date of Event
    April 27, 2023
    Report Date
    June 23, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) . INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A24. PATIENT PROBLEM CODE: F02.

    Additional Manufacturer Narrative · 0

    (B)(4).SUPPLEMENTAL MDR DEVICE EVALUATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. THE RECORD WAS OPENED AFTER EVALUATION OF A LITERATURE REVIEW PERFORMED FOR THE CREATION OF THE CLINICAL EVALUATION REPORT FOR THE PLUERX CATHETER. THE LITERATURE WAS EVALUATED FOR MALFUNCTIONS, SERIOUS INJURIES AND DEATHS. NO PRODUCT CODE OR BATCH INFORMATION WAS IDENTIFIED TO AIDE IN THE INVESTIGATION. THE RMF-0006-IS SYSTEM HAZARD ANALYSIS IS REV 18 WAS REVIEWED AND THE ASSOCIATED PATIENT OUTCOME IS IDENTIFIED IN MULTIPLE AREAS OF THE RMF DOCUMENT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE MANUFACTURE NARRATION

    Description of Event or Problem · 0

    VERBATIM: DEATHS: 1.

    Description of Event or Problem · 0

    VERBATIM: DEATHS: 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897732 UNKNOWN PLEURX APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death