BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 2080631 · Received April 25, 2011

    Report

    Report Number
    9615050-2011-00291
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 14, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY OF CRITICAL THERAPY FOLLOWING AN ALARM CONDITION. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF LEVOPHED, AT A RATE OF 13MCG/MIN AND THE DELIVERY WAS STATED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT 1500, THE NURSE NOTED THE DELIVERY HAD STOPPED. AT THIS TIME, THE DISPLAY OF THE DEVICE WAS WHITE AND THE TOUCHSCREEN DID NOT RESPOND. IT WAS UNSPECIFIED IF THERE WAS AN AUDIBLE ALARM TONE. AT THAT TIME, THE NURSE REPORTED A DECREASE IN THE PT'S BLOOD PRESSURE TO 60/30MHG. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE PHYSICIAN WAS NOTIFIED. AT THIS TIME, THE PT WAS TREATED WITH PHENYLEPHRINE 100MG IVP. A SECOND 100MG DOSE OF PHENYLEPHRINE WAS GIVEN 10 MINUTES LATER. A REPLACEMENT DEVICE WAS PROGRAMMED TO DELIVER LEVOPHED 16MCG/MIN AND THE THERAPY WAS REUSED. IT WAS REPORTED THAT FOR THE NEXT 1.5 HOURS, THE DELIVERY RATE WAS TITRATED TO 13MCG/MIN TO MAINTAIN A MEAN BLOOD PRESSURE OF 60MMHG. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THE PT WAS "STABLE." THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEVOPHED: MFR UNK