BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 8685100 · Received June 10, 2019

    Report

    Report Number
    2016493-2019-00624
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 14, 2019
    Report Date
    May 16, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT INFORMATION: DIAGNOSIS: FEVER NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2019 AT 0151 A PRIMARY INFUSION OF AN SODIUM GLYCEROPHOSPHATE 20MML/250ML WAS PROGRAMMED TO INFUSE FOR 8 HOURS. ON (B)(6) 2019 AT 0231 THE RN ENTERED THE PATIENT'S ROOM TO FIND THAT THE IV BAG WAS EMPTY. THE CUSTOMER LATER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE ADULT PATIENT FROM THE EVENT.

    Additional Manufacturer Narrative · 1

    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 AGE AND DOB REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSION OF AN UNSPECIFIED MEDICATION 250ML PROGRAMMED TO INFUSE FOR 8 HOURS WAS INITIATED ON (B)(6) 2019 AT 0151. ON (B)(6) 2019 AT 0231 THE RN ENTERED THE PATIENT'S ROOM TO FIND THAT THE IV BAG WAS EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476250 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR 2420-0007,8015, (B)(6) 2019