BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 2842176 · Received November 15, 2012

    Report

    Report Number
    9615050-2012-01349
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING. ALTHOUGH THE DEVICE PASSED TESTING, A REVIEW OF THE HISTORY INDICATED A WHITESCREEN ERROR. THE WHITESCREEN ERROR OCCURRED WHEN THE USER TITRATED ONLY THE RATE WHEN THE DEVICE WAS DELIVERING IN THE KVO MODE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY INDICATES THAT ON (B)(4) 2012 AT 1149, CHANNEL A OF THE DEVICE WAS PROGRAMMED SUING THE DRUG LIBRARY TO DELIVER LEVOPHED, AT A TITRATED DOSE OF 15MCG/MIN, DELIVER AT END OF INFUSION SETTING WAS CONTINUE RATE AND THE DELIVERY WAS STARTED. AT 1155, AN END OF INFUSION ALARM OCCURRED, KVO DELIVERY WAS STARTED, THE ALARM WAS CLEARED. AT 1159, KVO WAS STOPPED. NO POWER OFF WAS INDICATED AT THAT TIME. ON (B)(4) 2012 AT 1013, THE DEVICE WAS POWERED ON, A POST SW (SOFTWARE), A S308 (CAN BUS ERROR), A S408 (CAN BUS ERROR) OCCURRED. AT 1014, THE DEVICE WAS POWERED OFF. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY IN CRITICAL THERAPY FOLLOWING AN ALARM CONDITION. AT AN UNSPECIFIED TIME, AN UNSPECIFIED CHANNEL OF THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF LEVOPHED AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE REPORTED THE DEVICE ALARMED INDICATING THE VTBI (VOLUME TO BE INFUSED) WAS COMPLETE. AT THAT TIME, THE NURSE REPORTED WHILE ATTEMPTING TO REPROGRAM THE DEVICE TO DECREASED THE DELIVERY RATE AND VTBI, THE DEVICE DISPLAYED A WHITESCREEN ERROR MESSAGE. AT THAT TIME, THE NURSE REPORTED THE PT'S SYSTOLIC BLOOD PRESSURE DECREASED FROM THE 140'S MMHG INTO THE 60'S MMHG. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE AND TUBING SET. AT THAT TIME, THE DELIVERY RATE WAS INCREASED TO AN UNSPECIFIED RATE. THE CUSTOMER CONTACT REPORTED THAT A COUPLE OF MINUTES AFTER THE DELIVERY WAS RESTARTED, THE PT'S BLOOD PRESSURE STABILIZED TO AN UNSPECIFIED LEVEL. 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 79 YR Life Threatening| R LEVOPHED