BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SE PUMP

    MDR report key: 2140765 · Received June 15, 2011

    Report

    Report Number
    2016493-2011-00377
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 23, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K931549
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: (B)(4) 2011. (B)(4). THE CUSTOMER'S REPORT THAT THE DEVICE FAILED TO DETECT AIR COULD NOT BE CONFIRMED. DATA FROM THE DEVICE'S EVENT HISTORY LOG INDICATES THAT THE BLOOD INFUSION DID END IN AN AIR IN LINE ALARM WITH OVER 44MLS OF FLUID LEFT TO INFUSE. TESTING WITH THE RETURNED USED DISPOSABLE SET, WITH THE SEGMENT OF BLOOD ALIGNED WITH THE AIR DETECTOR, FAILED TO REPLICATE THE REPORTED ISSUE. EACH ATTEMPT TO START AN INFUSION RESULTED IN AN AIR IN LINE ALARM IMMEDIATELY. AIR IN LINE TESTING AT THE INCIDENT RATE AND AIR IN LINE SETTINGS FOUND THE DEVICE TO BE DETECTING AIR WITHIN SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED FAILURE TO ALARM FOR AIR IN LINE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AT THE END OF A BLOOD TRANSFUSION TO A PATIENT IN PEDIATRICS, AIR PASSED THROUGH THE PUMP AND THE PUMP DID NOT ALARM FOR AIR-IN-LINE AND KEPT INFUSING UNTIL ALMOST THE ENTIRE TUBING WAS FILLED WITH AIR. THE NURSE NOTED THE ISSUE BEFORE THE AIR REACHED THE PATIENT AND STOPPED THE INFUSION. THERE WAS NO PATIENT HARM REPORTED. THE PATIENT WAS ORDERED FOR 1 UNIT OF BLOOD OVER 4 HOURS. THE UNIT WAS 340MLS VOLUME; RATE WAS 85ML/HR. CUSTOMER STATES NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE. HOSPITAL BIOMED RECEIVED THE PUMP AND THE TUBING. THE PUMP TESTED WITHIN SPECIFICATION. THERE WERE A FEW BLOOD DROPS WITHIN THE SET. HE NOTED THAT ONE DROP WAS HANGING COMPLETELY CENTERED OVER THE AIL SENSOR AND HE BELIEVES THAT MAY HAVE CAUSED IT NOT TO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE PUMP FRN CAREFUSION CORPORATION 7100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK (2) USED SE PUMP MODULE ADMINISTRATION SET: (B)(4)