BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 6897583 · Received September 27, 2017

    Report

    Report Number
    2016493-2017-00611
    Event Type
    Malfunction
    Date Received
    September 27, 2017
    Date of Event
    March 5, 2017
    Report Date
    August 17, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: (2)2420-0007;SYR TUBE; 250 ML EXACTA MIX INFUSION BAG (LOT 1183562 EXP 2019-09-30), 100 ML HOSPIRA INFUSION BAG (LOT 170400112M EXP 05-10-2017); THERAPY DATE (B)(6) 2017. CONCLUSION CODE: FIELD LEFT BLANK- NO AVAILABLE CODE FOR UNDETERMINED OR UNKNOWN CAUSE. THE CUSTOMER¿S REPORT OF A CHANNEL ERROR ALARM WAS CONFIRMED. REVIEW OF THE PCU ERROR LOG SHOWS THAT THERE WERE FOUR CHANNEL ERROR 240.4150.0 EVENTS BETWEEN 5:52 PM AND 7:56 PM ON (B)(6) 2017. PRIOR TO THE FIRST CHANNEL ERROR, THE PUMP WAS PROGRAMMED FOR FENTANYL AT 5:12 PM. AFTER THE FIRST 3 CHANNEL ERRORS THE INFUSIONS WERE RESTORED AND THE PUMP WAS STARTED; FOLLOWING THE FOURTH EVENT, THE USER CHANNELED OFF THE PUMP AT 8:07 PM. TESTING INDICATED THAT THE BOTTLE SIDE PRESSURE SENSOR WAS INTERMITTENTLY PRODUCING RAILED OUTPUT VOLTAGE OF 4.96 VOLTS. REPLACEMENT OF THE SENSOR WITH A GOOD KNOWN COMPONENT RECTIFIED THE ISSUE, INDICATING A FAILED PRESSURE SENSOR COMPONENT. THE CAUSE OF THE CHANNEL ERROR WAS A FAULTY BOTTLE SIDE PRESSURE SENSOR. THE CAUSE OF THE FAILED SENSOR IS LIKELY RELATED TO A FAULTY INTERNAL SENSOR CIRCUIT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN INFUSION OF FENTANYL CITRATE (1,500 MCG/100 ML), IN THE NICU PROFILE, A CHANNEL ERROR ALARM OCCURRED. NO PATIENT HARM WAS REPORTED. ALSO INFUSING AT THE TIME OF THE EVENT WAS A TPN 250 ML BAG CONTAINING AMINO ACIDS 3%, DEXTROSE 10% WITH CALCIUM AND HEPARIN IN STERILE WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677019 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA