BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ TWO-CHANNEL INFUSION SYSTEM

    MDR report key: 1170270 · Received September 11, 2008

    Report

    Report Number
    2921482-2008-00280
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 15, 2008
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. THE DEVICE PASSED TESTING AT THE USER FACILITY. THE PUMP HISTORY WAS DOWNLOAD AT THE USER FACILITY. A REVIEW OF THE HISTORY INDICATES IN 2008 AT 1402, CHANNEL B WAS PROGRAMMED IN BASIC THERAPY TO DELIVER AMIODARONE, WITH A DRUG CONCENTRATION OF 150MG/100ML, AT A RATE OF 618ML/HR, WITH A VTBI OF 150ML, FOR A CALCULATED DURATION OF 15 MIN, DELIVER AT END OF INFUSION SETTING: CONTINUE RATE, DISTAL OCCLUSION SETTING 12PSI, AND PROXIMAL OCCLUSION SETTING OF SOLUTION CONTAINER. THE INFUSION WAS STARTED, A PROXIMAL OCCLUSION ALARM OCCURRED, CLEARED, AND THE INFUSION WAS RESUMED. AT 1417, END OF INFUSION ALARM OCCURRED WITH A VOLUME INFUSED OF 150ML, DRUG AMOUNT INFUSED OF 225MG, AND KVO DELIVERY STARTED. AT 1431, THE INFUSION WAS STOPPED WITH A KVO AMOUNT INFUSED OF 146.146ML. CHANNEL B WAS REPROGRAMMED IN BASIC THERAPY TO DELIVER AMIODARONE 450MG/250ML, DOSE RATE 1MG/MIN, CALCULATED RATE OF 33.333ML/HR, VTBI OF 200ML, FOR A CALCULATED DURATION OF 6 HOURS, AND DELIVERY STARTED. AT 1445, SHIFT TOTAL WAS CLEARED. AT 1602, THE INFUSION WAS STOPPED WITH A VOLUME INFUSED OF 42.865ML, AND DRUG AMOUNT INFUSED OF 77.157MG. BETWEEN 1604 AND 1607, CALLBACK ALARMED OCCURRED, CLEARED AND STANDBY MODE ENTERED. AT 1707, THE CASSETTE WAS EJECTED AND LOADED. BETWEEN 1710 AND 1725, STANDBY MODE WAS CANCELLED, CALLBACK ALARM OCCURRED, CLEARED, AND THE PUMP WAS POWERED OFF. A REVIEW OF THE HISTORY INDICATED THAT THE DEVICE DELIVERED AS PROGRAMMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT RECEIVED MORE MEDICATION THAN INTENDED. IN 2008, AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AMIODARONE AT A RATE OF 33ML/HR FOR A DURATION OF 6 HOURS. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT 1430, THE DELIVERY WAS STARTED. AT 1600, IT WAS NOTED THAT THE SOLUTION CONTAINER WAS EMPTY. THE NURSE REPORTED THE PT'S BLOOD PRESSURE DECREASED TO AN UNSPECIFIED LEVEL. NO MEDICAL INTERVENTIONS WERE REPORTED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AMIODARONE MFR UNK