BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASEAL

    MDR report key: 10173505 · Received June 19, 2020

    Report

    Report Number
    10173505
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    April 28, 2020
    Report Date
    May 18, 2020
    Manufacturer
    BD
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED THE RN AS THE IV PUMP WAS BEEPING. ANTHER RN WENT TO CHECK THE PUMP AND IT WAS SHOWING "PARTIAL OCCLUSION," SO THE RN CHECKED THE TUBING FROM TOP TOWARDS PATIENT SIDE. WHILE HOLDING AND CHECKING THE TUBING, THE RN NOTICED THAT IT WAS DISCONNECTED FROM THE HUB OF HEP CAP OF CVC. RN CALLED PRIMARY RN AND CLEANED WITH PREVENTICS AND RECONNECTED BACK TO THE TUBING. THEN THE CHARGE NURSE WAS CALLED AND RECHECKED THE TUBING/IV AND ADVISED TO CHANGE THE OPTIMA CONNECTOR AND CONNECT A NEW ONE AND SECURE IT. A NEW OPTIMA CONNECTOR WAS PLACED. MANUFACTURER RESPONSE FOR IV CONNECTOR,AND INJECTOR, QBD PHASEAL OPTIMA (PER SITE REPORTER). OPTIMA REPS FROM WITHIN (B)(6) WILL BE MAKING ARRANGEMENTS TO COME ON-SITE TO ROUND, OBSERVE, AND DISCUSS WITH STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638758 PHASEAL SET, I.V. FLUID TRANSFER LHI BD C 35-0 1910101

    Patients

    Seq Age Sex Outcome Treatment
    1 10585 DA