BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE MODULE

    MDR report key: 7385279 · Received March 30, 2018

    Report

    Report Number
    2016493-2018-00283
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    February 24, 2018
    Report Date
    March 5, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K023264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: BD 50ML SYRINGE, (2)SYR TUBE; 8110; THERAPY DATE (B)(6) 2018. THE CUSTOMER¿S REPORT OF AN OVERINFUSION WAS CONFIRMED. ANALYSIS OF THE PCU EVENT LOG SHOWS THAT THE SYRINGE MODULE WAS INFUSING HYDROMORPHONE DRIP CHILD 1MG/1ML AT A RATE OF 0.44ML/HR WITH (B)(6) AND DOSE OF 0.04MG/KG/HR. AT 10:33 AM ON (B)(6) 2018, AFTER SEVERAL DOSE/RATE CHANGES AND A CHANGE TO (B)(6), THE USER CHANGED THE DOSE TO 0.01MG/KG/HR, WHICH MADE THE RATE 0.11ML/HR. AT 11:25 AM, THE USER PROGRAMMED A RAPID BOLUS OF 0.01MG/KG (VTBI = 0.11ML). AT 11:27 AM, THE USER PROGRAMMED A RAPID BOLUS OF 0.1MG/KG (VTBI = 1.1ML). AT 8:11 PM, THE USER SELECTED BOLUS AND RESTORE (DOSE = 0.1MG/KG). THE USER CHANGED THE DOSE TO 0.01MG/KG. AT 8:14 PM, THE BOLUS COMPLETED AND THE DEVICE TRANSITIONED TO THE CONTINUOUS INFUSION RUNNING AT 0.11ML/HR. THE ROOT CAUSE OF THE OVERINFUSION WAS USER PROGRAMMING IN ENTERING A BOLUS DOSE AT TEN TIMES THE INTENDED DOSE. NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT WITH AN ADVANCED AIRWAY IN PLACE AND VENTILATOR SUPPORT WAS RECEIVING CONTINUOUS HYDROMORPHONE. THE INTENDED PARAMETERS WERE 1MG/ML IN 50 ML NS, DOSE 0.01 MG/KG/HR (0.11 MG/HR BASED ON (B)(6)), BOLUS 0.01MG/KG X 11KG (DOSE 0.11MG) TO BE GIVEN EVERY 1 HOUR AS NEEDED, PROGRAMMED AS A BOLUS OFF THE INFUSION. THE RN WENT TO GIVE A BOLUS THROUGH THE SYRINGE PUMP AND NOTICED THAT THE DOSE WAS PROGRAMMED 10 TIMES MORE THAN WHAT WAS ORDERED. IT IS UNKNOWN IF ANY DOSES WERE ADMINISTERED TO THE PATIENT BEFORE THE ERROR WAS DETECTED. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227892 ALARIS SYRINGE MODULE PUMP, INFUSION FRN CAREFUSION 8110

    Patients

    Seq Age Sex Outcome Treatment
    1