BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYMBIQ 3.13 SINGLE C

    MDR report key: 3070686 · Received April 15, 2013

    Report

    Report Number
    9615050-2013-00723
    Event Type
    Death
    Date Received
    April 15, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 21, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 A WHITESCREEN ERROR. AT 1528 DURING A PATIENT CODE, THE DEVICE WAS PROGRAMMED TO DELIVER NOREPINEPHRINE 8 MG/250 ML, AT A RATE OF 16 MCG/MIN, WITH A VTBI (VOLUME TO BE INFUSED) OF 5.020 ML, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT 1538, THE NURSE REPORTED THE DEVICE DISPLAY WAS WHITE, WITH AN UNSPECIFIED SOFTWARE FAILURE AND THE DEVICE BECAME INOPERABLE. AT THAT TIME, THE NURSE ATTEMPTED TO EJECT THE TUBING SET FROM THE DEVICE USING THE EMERGENCY EJECT LEVER; HOWEVER, THE NURSE WAS UNABLE TO EJECT THE TUBING SET FROM THE DEVICE. THE DEVICE AND TUBING SET WERE REMOVED FROM CLINICAL USE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE THERAPY WAS RESUMED USING A REPLACEMENT DEVICE, TUBING SET AND MEDICATION CONTAINER. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THE PATIENT EXPIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161087 SYMBIQ 3.13 SINGLE C 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death NOREPINEPHRINE: MANUFACTURER UNK