BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEUR-EVAC

    MDR report key: 19358309 · Received May 21, 2024

    Report

    Report Number
    19358309
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    February 18, 2024
    Report Date
    February 28, 2024
    Manufacturer
    TELEFLEX, INC.
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS EVENT IS AN IMPROVEMENT RECOMMENDATION FOR THIS PRODUCT'S PACKAGING. SITUATION: REGISTERED NURSE (RN) NOTED THAT RIGHT PLEUR-EVAC SAHARA WATER CHAMBER WAS EMPTY. BACKGROUND: THE RIGHT PLEUR-EVAC SAHARA WAS CHANGED, HOWEVER THAT NURSE FORGOT TO INSTILL WATER IN TO WATER CHAMBER. ASSESSMENT: THE WATER SYRINGE THAT COMES IN A KIT WAS FOUND STILL ATTACHED TO THE BACK. RESOLUTION: REMIND NURSES ABOUT PLEUR-EVAC SAHARA UP AND SAFETY CHECKS. LEADERSHIP AND PATIENT SAFETY HAVE REVIEWED EVENT AND WILL MAKE REQUEST AND NOTIFY TO MEDSUN AND MANUFACTURER TO CHANGE PACKAGING - HAVING SYRINGE IN FRONT OF SET UP (IF POSSIBLE). THE WATER SEAL CHAMBER OF THE PLEUR-EVAC WAS NOT FILLED AND REMAINED EMPTY FOR THE FIRST 48 HOURS OF USE. THE SYRINGE TO FILL THE WATER SEAL CHAMBER ON THE PLEUR-EVAC IS LOCATED IN A HIDDEN SPOT ON THE BACK OF THE PLEUR-EVAC. THIS IS A REPEAT EVENT AND WOULD APPRECIATE THE SYRINGE BEING ATTACHED TO THE FRONT OF THE PLEUR-EVAC TO ENSURE THE PERSON SETTING UP THE PLEUR-EVAC SEES THE SYRINGE AND IS REMINDED TO ADD THE WATER TO THE WATER SEAL CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617867 PLEUR-EVAC APPARATUS, AUTOTRANSFUSION CAC TELEFLEX, INC. 2620 800

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female