BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 1910983 · Received November 23, 2010

    Report

    Report Number
    2921482-2010-00942
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 26, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN REC'D. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT REC'D MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, ON AN UNSPECIFIED CHANNEL, THE DEVICE WAS PROGRAMMED TO DELIVER NORMAL SALINE, AT A RATE OF 60ML/HR AND THE DELIVERY WAS STARTED. ON (B)(6) 2010 AT 1540, THE DEVICE WAS PROGRAMMED FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF MAGNESIUM SULFATE, AT A RATE OF 25ML/HR, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT 1601, THE NURSE NOTED THE MAGNESIUM SULFATE CONTAINER WAS EMPTY. IT WAS UNSPECIFIED THE VOLUME OF MAGNESIUM SULFATE THAT WAS EXPECTED TO BE REMAINING IN THE CONTAINER. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THE CUSTOMER CONTACT REPORTED THE PT WAS TREATED WITH UNSPECIFIED ELECTROLYTE REPLACEMENT FOR "ECTOPY ON THE ECG." THE CUSTOMER CONTACT COULD NOT SPECIFY IF THE MAGNESIUM WAS THE CAUSE OF THE ECTOPY. THOUGH REQUESTED, THE CUSTOMER CONTACT HAS DECLINED TO PROVIDE ADD'L INFO.

    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 Required Intervention