BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 8215774 · Received January 3, 2019

    Report

    Report Number
    2016493-2019-00052
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    November 30, 2018
    Report Date
    December 4, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A DEVICE SHUT OFF AFTER IT HAD BEEN INFUSING IN THE NICU. AT 1940, IT WAS DISCOVERED THE DEVICE, WHICH HAD BEEN INFUSING NEONATAL VENOUS NUTRITION (NVN), WAS COMPLETELY SHUT OFF. FROM REVIEWING RECORDS, THE CUSTOMER WAS ABLE TO DETERMINE THE FLUIDS HAD STOPPED INFUSING AT 1810. THE NURSE THEN WENT TO FLUSH THE LINE, AND WAS UNABLE TO DO SO WHICH RESULTED IN THE LICENSED INDEPENDENT PRACTITIONER TAKING DOWN THE INFUSION LINE AND FLUSHING THE PATIENT'S PICC LINE. TUBING WAS CHANGED AND THE INFUSION WAS RESTARTED. THE DEVICE ALARMED OCCLUSION SHORTLY THEREAFTER, BUT THE INFUSION WAS ABLE TO BE RESTARTED. NO FURTHER OCCLUSIONS OR ISSUES WERE EXPERIENCED AFTER THE "SETUP" WAS CHANGED OUT. THE CUSTOMER REPORTS THAT NO FURTHER INFORMATION IS AVAILABLE. THERE'S NO REPORT OF PATIENT HARM.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PICC LINE 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. PATIENT WAS AN INFANT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A DEVICE SHUT OFF AFTER IT HAD BEEN INFUSING IN THE NICU. AT 1940, IT WAS DISCOVERED THE DEVICE, WHICH HAD BEEN INFUSING NEONATAL VENOUS NUTRITION (NVN), WAS COMPLETELY SHUT OFF. FROM REVIEWING RECORDS, THE CUSTOMER WAS ABLE TO DETERMINE THE FLUIDS HAD STOPPED INFUSING AT 1810. THE NURSE THEN WENT TO FLUSH THE LINE, AND WAS UNABLE TO DO SO WHICH RESULTED IN THE LICENSED INDEPENDENT PRACTITIONER TAKING DOWN THE INFUSION LINE AND FLUSHING THE PATIENT'S PICC LINE. TUBING WAS CHANGED AND THE INFUSION WAS RESTARTED. THE DEVICE ALARMED OCCLUSION SHORTLY THEREAFTER, BUT THE INFUSION WAS ABLE TO BE RESTARTED. NO FURTHER OCCLUSIONS OR ISSUES WERE EXPERIENCED AFTER THE "SETUP" WAS CHANGED OUT. THE CUSTOMER REPORTS THAT NO FURTHER INFORMATION IS AVAILABLE. THERE'S NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4294 ALARIS® PUMP MODULE INFUSION PUMP FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA PRI TUBING,8015, TD (B)(6) 2018