BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI-FLOW MODEL 4000 PLUS

    MDR report key: 1060235 · Received June 12, 2008

    Report

    Report Number
    2921482-2008-00183
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    April 10, 2008
    Report Date
    May 20, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K882594
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPITAL PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PUMP DID NOT DELIVER. AT AN UNSPECIFIED TIME, THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF DOBUTAMINE WITH A DOSE OF "10 MCG" AND AN UNSPECIFIED CONCENTRATION OF DOPAMINE WITH A DOSE OF "2.5 MCG". NO PROGRAMMING PARAMETERS WERE PROVIDED. AT 2045, IT WAS NOTED THAT THE PT'S BLOOD PRESSURE WAS "IN THE 50'S". THE CUSTOMER CONTACT REPORTED THAT UNSPECIFIED DOSES OF ALBUMIN, CALCIUM AND LEVOPHED, WERE INITIATED AND THE PT'S BLOOD PRESSURE WAS REPORTED TO INCREASE TO THE "80'S". THE NURSE NOTED THAT THE DEVICE "LIGHTS WERE ON LIKE IT WAS RUNNING AND IT WAS NOT RUNNING AND IT WAS NOT ALARMING." THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT PUMP AND "IMMEDIATELY THE BLOOD PRESSURE RESPONDED." THERE WERE NO REPORTED ADVERSE PT SEQUELAE. DURING TESTING AT THE USER FACILITY, THE DEVICE "PASSED FUNCTIONAL TESTING FOR DELIVERY ACCURACY, OCCLUSION TESTING, AND FOR AUDIBLE ALARM." THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI-FLOW MODEL 4000 PLUS 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R DOBUTAMINE| DOPAMINE