BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMBIQ DCHANNEL 3.01

    MDR report key: 3111650 · Received May 7, 2013

    Report

    Report Number
    9615050-2013-01060
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 9, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AIR IN THE TUBING SET DISTAL TO THE DEVICE WITH NO DEVICE ALARM. ON AN UNSPECIFIED DATE AND TIME, AN UNSPECIFIED CHANNEL OF THE DEVICE WAS PROGRAMMED FOR BASIC DELIVERY OF LACTATED RINGERS, A VTBI (VOLUME TO BE INFUSED) OF 1000 ML AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE DEVICE WAS PROGRAMMED FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF VITAMIN K, WITH A VTBI OF 50 ML, AT A RATE OF 300 ML/HR, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER APPROXIMATELY TEN MINUTES, THE NURSE REPORTED THE DISPLAY INDICATED THAT 5 ML REMAINED TO BE DELIVERED; HOWEVER, THE CONTAINER WAS FULL. AT THIS TIME, THE NURSE NOTED SEGMENTS OF AIR PROXIMAL AND DISTAL TO THE DEVICE WITH NO DEVICE ALARM. AT THAT TIME, THE DELIVERY WAS STOPPED. THE AIR WAS CLEARED FROM THE TUBING SET AND THE DELIVERY WAS RESTARTED. THE DEVICE IMMEDIATELY ALARMED FOR AIR IN LINE. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. IT WAS REPORTED THAT 10 MINUTES LATER, THE THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO DELAY IN THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE PT WAS MONITORED IN THE SICU (SURGICAL INTENSIVE CARE UNIT). AFTER AN UNSPECIFIED LENGTH OF TIME, THE PT WAS TRANSFERRED TO A GENERAL MEDICAL SURGICAL UNIT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200028 SUMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR