BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 1590996 · Received January 28, 2010

    Report

    Report Number
    2921482-2010-00034
    Event Type
    Other
    Date Received
    January 28, 2010
    Date of Event
    December 28, 2009
    Report Date
    December 30, 2009
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. THE DEVICE PASSED TESTING AT THE USER FACILITY AND WAS RETURNED TO CLINICAL SERVICE. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN UNSPECIFIED OPERATOR ERROR, WHICH RESULTED IN THE PATIENT RECEIVING MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF DILAUDID. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT INDICATED THE PATIENT WHO HAD A RESUSCITATE ORDER (DNR) WAS BEING TREATED IN HOSPICE CARE FOR AN UNSPECIFIED DIAGNOSIS. THE PATIENT WAS REPORTED TO HAVE A LIFE EXPECTANCY OF 2 DAYS. ON (B)(6) 2009 AT AN UNSPECIFIED TIME, THE PATIENT EXPIRED. THE CUSTOMER CONTACT REPORTED THIS "WAS HUMAN ERROR, NOT EQUIPMENT." THOUGH REQUESTED, THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION INCLUDING THE PATIENT'S AGE, GENDER, DIAGNOSIS, MEDICATION CONCENTRATION, ANY MEDICAL INTERVENTIONS THAT WERE PROVIDED, THE TIMEFRAME OF THE EVENT, AND THE SPECIFIC OPERATOR ERROR. THE CUSTOMER CONTACT STATED, "THIS EVENT IS NOT RELATED TO THE PUMP-SO INFORMATION YOU NEED IS NOT APPLICABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death DILAUDID