BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 7358658 · Received March 21, 2018

    Report

    Report Number
    2016493-2018-00280
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Report Date
    March 5, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY HAD DEVICES THAT WERE REPORTED TO BE INVOLVED IN AN OVER INFUSION HOWEVER THEY ARE UNABLE TO LOCATED THE DEVICES FOR INVESTIGATION. THE CUSTOMER ASKED IF THERE WAS A WAY TO TRACK THE DEVICES WITH AN EMR NUMBER. THERE WAS NO REPORT OF PATIENT HARM. THE CUSTOMER LATER STATED THEY HAVE CONCLUDED THEIR INVESTIGATION INTO THIS MATTER AND THEY WERE UNABLE TO COLLECT THE PHYSICAL EQUIPMENT AND CONSUMABLES INVOLVED IN THIS INCIDENT. THEY HAVE INSPECTED ALL BD/CAREFUSION INFUSION DEVICES IN THE FACILITY'S DEPARTMENT WHERE THIS OCCURRED AND THEY REPORTED NO VISIBLE CRACKS OR DAMAGE TO THE HINGES OF THE DEVICES. THEY DON¿T THINK THEY WILL NEED BD/CAREFUSION¿S ASSISTANCE TO FURTHER INVESTIGATE THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202760 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1