BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 8969911 · Received September 6, 2019

    Report

    Report Number
    2016493-2019-01121
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Report Date
    August 8, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WAS AN ADULT. NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP MODULE WAS PROGRAMMED AT THE WRONG RATE FOR A NOREPINEPHRINE INFUSION. PATIENT ARRIVED VIA HELICOPTER 5/16/2109 WITH NOREPI INFUSING - CONCENTRATION WAS 4MG/250ML. NURSE USED THE BAG FROM TRANSPORT TEAM, CONNECTED TO ALARIS DEVICE AND MANUALLY PROGRAMMED THE NON-FORMULARY CONCENTRATION. INFUSION WAS MANUALLY PROGRAMMED AT 4:34 AM. DATASET DID ALLOW FOR PROGRAMMING OF NON-FORMULARY CONCENTRATION. DUE TO CRITICAL PATIENT, NURSE WAS ALLOWED TO USE THIS CONCENTRATION. BCMA SCAN WOULD HAVE PICKED UP ON THE CONCENTRATION BEING DIFFERENT FROM ORDERED CONCENTRATION, BUT BCMA WAS NOT COMPLETED AS THERE WAS NOT A PATIENT LABEL ON THE BAG. MEDICATION WAS TITRATED TO 20MIC/MIN OR 75 ML/HR OVER THE NEXT 4 PLUS HOURS. AT 9:17AM INFUSION WAS STOPPED AND NEW BAG WAS HUNG AND STARTED AT 9:18AM. THE NEW BAG WAS PREPOPULATED WITH THE A NEW CONCENTRATION OF 8MG/250ML - IN ORDER FOR THIS TO SUCCESSFULLY POPULATE THE PUMP THE MODULE IT HAD TO BE STOPPED AND PLACE IN AN IDLE STATE. THIS WOULD ELIMINATE ANY ABILITY TO USE MATCHING CRITERIA TO IDENTIFY SOMETHING WAS DIFFERENT WITH THE ORDER. THE DOSE OF 40MCG/MIN AND RATE OF 75ML/HR WERE SENT TO THE PUMP AT 9:18 (THIS IS ENTERED INTO EPIC PRIOR TO SENDING ORDER TO THE PUMP). NURSE ESSENTIALLY HELD THE RATE OF 75ML/HR INSTEAD OF THE DOSE 20MCG/MIN - FOR ABOUT 15 MINUTES. AT 9:33AM, DOSE WAS THEN ADJUSTED TO 20MCG/MIN OR 37.5 ML/HR - THE CORRECT STARTING DOSE/RATE FOR THE CONCENTRATION BASED ON THE INFUSION PRIOR TO CHANGING THE CONCENTRATION. THERE WAS NO PATIENT HARM.

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS REQUESTED, HOWEVER CUSTOMER DECLINED TO PROVIDE. ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP MODULE WAS PROGRAMMED AT THE WRONG RATE FOR A NOREPINEPHRINE INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763485 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR PRI TUBING, 8015, THERAPY DATE: UNK