BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS INFUSION PUMP

    MDR report key: 5959470 · Received September 16, 2016

    Report

    Report Number
    MW5064819
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    September 11, 2016
    Report Date
    September 16, 2016
    Manufacturer
    BECTON DICKINSON/AKA CAREFUSION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FREE FLOW OF PROPOFOL DRIP. PT INTUBATED IN ER FOR AIRWAY PROTECTION. PROPOFOL STARTED AT 5MCG/KG/MIN. WHILE TURNING PT A FEW MINUTES LATER, 2 OTHER RNS NOTICED THAT BOTTLE WAS MOSTLY EMPTY AND DRIPPING FAST. IMMEDIATELY PAUSED DRIP. LOOKED AT PROGRAM AND VERIFIED THAT CHANNEL WAS PROGRAMMED CORRECTLY AT 5MCG/KG/MIN. ATTEMPTED TO VOLUME OUT CHANNEL. PUMP BRAIN READ VOLUME INFUSED FOR THIS CHANNEL WAS 0.9ML. EVEN THOUGH WHEN MANUALLY EMPTIED AND BOTTLE THERE WAS ONLY 30ML LEFT (100ML IN ENTIRE BOTTLE). BP TAKEN IMMEDIATELY AND WAS 66/40; 1L BOLUS GIVEN WITH FREQUENT BP CHECKS EVERY 2 MINUTES. PT REPORTED TO BOLUS. PT AT END OF 1L BOLUS 94/56. CHANNEL AS DAMAGED. INSPECTION OF THE DEVICE REVEALED A CRACK OF THE OUTER DOOR HINGE. WE WERE PREVIOUSLY AWARE OF ALARIS HAVING ISSUES WITH FREE FLOW WHEN THE INNER HINGE IS CRACKED, BUT THIS INVOLVED THE OUTER DOOR. AN ALERT WAS SENT OUT TO NURSING TO EXAMINE AND SECURE ALL OTHER PUMPS WITH THIS DEFECT. TO DATE, 6 OTHER PUMPS WITH OUTER HINGE CRACKS HAVE BEEN IDENTIFIED (7 ALTOGETHER). FIVE OF THE PUMPS WITH DEFECTIVE CASING OF THE OUTER HINGE WERE MANUFACTURED IN 2006. ONE PUMP WAS FROM 2011 AND THE OTHER PUMP WAS FROM 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609411 ALARIS INFUSION PUMP INFUSION PUMP FRN BECTON DICKINSON/AKA CAREFUSION 10992188
    609412 ALARIS INFUSION PUMP INFUSION PUMP FRN BECTON DICKINSON/AKA CAREFUSION 10992188
    609413 ALARIS INFUSION PUMP INFUSION PUMP FRN BECTON DICKINSON/AKA CAREFUSION 10992188
    609414 ALARIS INFUSION PUMP INFUSION PUMP FRN BECTON DICKINSON/AKA CAREFUSION 10992188
    609415 ALARIS INFUSION PUMP INFUSION PUMP FRN BECTON DICKINSON/AKA CAREFUSION 10992188
    609416 ALARIS INFUSION PUMP INFUSION PUMP FRN BECTON DICKINSON / AKA CAREFUSION 10992188
    609417 ALARIS INFUSION PUMP INFUSION PUMP FRN BECTON DICKINSON/AKA CAREFUSION 10992188

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention