BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 1880829 · Received October 1, 2010

    Report

    Report Number
    2921482-2010-00754
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 2, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE PUMP HISTORY WAS DOWNLOADED AT THE MFG FACILITY. REVIEW OF THE PUMP HISTORY INDICATED THAT ON (B)(6) 2010 AT 0929, CHANNEL B PROGRAMMING WAS CONFIRMED FOR THE BASIC PROGRAM, USING THE DRUG LIBRARY, TO DELIVER INSULIN, WITH A CONCENTRATION OF 150 UNITS / 150 ML, A DOSE OF 2 UNITS/HR, TO DELIVER AT A RATE OF 2 ML/HR. VTBI (VOLUME TO BE INFUSED) 50 ML, FOR A DURATION OF 25 HRS AND THE DELIVERY WAS STARTED. AT 1007, CHANNEL A PROGRAMMING WAS CONFIRMED FOR THE BASIC PROGRAM, USING THE DRUG LIBRARY, TO DELIVER DOPAMINE, WITH A CONCENTRATION OF 800 MG/250 ML, WITH A TITRATED DOSE OF 2 MCG/KG/MIN, WEIGHT 85 KG, AT A CALCULATED RATE OF 3.18 ML/HR, VTBI (VOLUME TO BE INFUSED) 244.249 ML, FOR A DURATION OF 76 HRS AND 38 MINS, AND THE DELIVERY WAS STARTED. BETWEEN 1008 AND 1118, AN ERROR CODE S233 (HIGH AMBIENT TEMPERATURE) OCCURRED AND WAS SILENCED EVERY TWO MINUTES. AT 1120, AN S233 ALARM IS CLEARED. BETWEEN 1219 AND 1241, AN ERROR CODE S233 OCCURRED AND WAS SILENCED EVERY TWO MINUTES. AT 1241, A BATTERY ALARM POWER OFF OCCURRED. 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 IN CRITICAL THERAPY FOLLOWING AN ALARM CONDITION. AT AN UNSPECIFIED TIME, AN UNSPECIFIED CHANNEL OF THE DEVICE WAS PROGRAMMED TO DELIVER DOPAMINE 800 MG/250 ML, AT A RATE OF "2-3 MCG/HR." THE SECOND CHANNEL OF THE DEVICE WAS PROGRAMMED TO DELIVER INSULIN AT A RATE OF 2 UNITS/HR AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT APPROX 1130 WHILE THE PT WAS BEING TRANSFERRED FROM THE OPERATING ROOM TO THE INTENSIVE CARE UNIT, THE CUSTOMER CONTACT REPORTED THE DEVICE ALARMED WITH AN UNSPECIFIED ERROR CODE AND THEN POWERED OFF. THE DEVICE WAS REMOVED FROM APPROX 2 MINUTES USING A REPLACEMENT DEVICE. ALTHOUGH THERE WAS POTENTIAL FOR SERIOUS INJURY, THE CUSTOMER CONTACT REPORTED THE PT'S STATUS WAS UNCHANGED. NO MEDICAL INTERVENTIONS WERE REQUIRED. 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, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR