BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 6494645 · Received April 14, 2017

    Report

    Report Number
    2016493-2017-00257
    Event Type
    Injury
    Date Received
    April 14, 2017
    Date of Event
    March 9, 2017
    Report Date
    March 21, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE INVESTIGATION DETERMINED THAT THE SUSPECT DEVICE IS NOW A DISPOSABLE PRODUCT AND REQUIRES A NEW MANUFACTURER REPORT NUMBER. PLEASE REFERENCE MANUFACTURER REPORT NUMBER 9616066-2017-00771 FOR MDR REPORTING.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 100ML FRESENUS KABI NDC 0338-0519-58, LOT 10KI9276, EXP 08/2018, INTRALIPD 20%; UMBILICAL VENOUS DOUBLE LUMEN CATHETER; THERAPY DATE (B)(6) 2017. THE DEVICE HAS BEEN RECEIVED AND AN EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A CRITICALLY ILL PATIENT WAS RECEIVING AN INTRALIPID INFUSION AT A RATE OF 0.4 ML/HR, AND TPN AT 2.7 ML/HR VIA DIFFERENT LUMENS OF A DOUBLE LUMEN UMBILICAL VEIN CATHETER. THE 100 ML LIPID INFUSION WAS STARTED ON (B)(6) 2017 (AT APPROXIMATELY 5 PM), AND EXPECTED TO INFUSE OVER APPROXIMATELY 22 HOURS. THE BAG WAS DISCOVERED TO BE EMPTY THE FOLLOWING MORNING AT 8 AM AT THE START OF A CODE RESUSCITATION. THE PATIENT WAS SUCCESSFULLY RESUSCITATED, AND NO SUSTAINED PATIENT EFFECTS OF THE EVENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275991 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Required Intervention 2260-0500,8015,