BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 6022799 · Received October 12, 2016

    Report

    Report Number
    9616066-2016-01423
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    March 15, 2016
    Report Date
    September 26, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS DISCARDED AND NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    RECEIVED A LETTER REQUESTING ADDITIONAL INFORMATION ABOUT CUSTOMER'S MEDSUN REPORT FROM FDA; ONLY A PARTIAL COPY OF THE CUSTOMER'S REPORT IS ATTACHED TO THE LETTER AND THE ACTUAL DESCRIPTION IS BLANK, HOWEVER THE CUSTOMER PROVIDED THE EVENT INFORMATION AS REPORTED TO MEDSUN, WHICH STATES: "PATIENT WAS RECEIVING IV FLUIDS AND POTASSIUM THROUGH A PIV. THE PRIMARY SET CONSISTED OF A CAREFUSION SMARTSITE INFUSION SET RUNNING THROUGH AN ALARIS PUMP AT 75 ML/HR. A SECOND SMARTSITE INFUSION SET WITH POTASSIUM WAS CONNECTED TO THE FIRST SET AT THE DISTAL SMARTSITE PORT OF THE FIRST SET. THE PUMP HAD ALARMED SEVERAL TIMES WITH AN OCCLUDED LINE CONDITION. STAFF REPORTED THIS WAS NOT UNUSUAL FOR A PIV IN THE BACK OF THE HAND. THE PUMP HAD ALARMED AND THE COVERING NURSE ENTERED THE ROOM AND RESET THE PUMP. SHORTLY THEREAFTER, THE PATIENT CALLED THE NURSES STATION TO REPORT THAT SHE WAS BLEEDING. NURSES RESPONDED TO THE ROOM TO FIND THE TUBING FROM THE SECOND SET HAD DISCONNECTED AT THE MALE LEUR LOCK FITTING AND BLOOD WAS BACKING UP FROM THE PRIMARY SET ONTO THE FLOOR AND BEDDING. POST INCIDENT INVESTIGATION SHOWED THE TUBING FROM THE SECOND SET HAD PHYSICALLY SEPARATED FROM THE BODY OF THE MALE LEUR LOCK LEAVING THE LEUR LOCK IN PLACE IN THE SMARTSITE." NO FURTHER INFORMATION IS AVAILABLE. THERE IS NO REPORT OF MEDICAL INTERVENTION OR PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675342 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007

    Patients

    Seq Age Sex Outcome Treatment
    1