BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3779672 · Received April 16, 2014

    Report

    Report Number
    9616066-2014-00400
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    March 15, 2014
    Report Date
    March 27, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS DISCARDED AND NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    ANECDOTAL REPORT RECEIVED FROM THE CUSTOMER, WHO SUSPECTS THAT A D10 INFUSION BACKED UP INTO A TPN BAG. A PATIENT IN THE ICU HAD 1000ML OF D10 INFUSING AT 75ML/HR, AN D2700ML OF TPN INFUSING GAT 83.3ML/HR ON A SECOND CHANNEL. THE NURSE NOTED THAT THE TPN BAG WAS GETTING FULLER (THE VOLUME WAS REPORTED TO BE APPROXIMATELY 3000 ML), AND THE PATIENT'S BLOOD SUGAR WAS DECREASING. REPORTEDLY THE D10 WAS EMPTYING, AND THE PUMP ALARMED FOR "NO VOLUME". THE PATIENT HAD A DUAL PROT CVL; THE NURSE FOUND THAT ONE OF THE PORTS WAS CLOTTED, BUT REPORTEDLY NO OCCLUSION ALARMS OCCURRED. THE CUSTOMER STATED THAT THE INFUSION WAS SET-UP CORRECTLY, HOWEVER, NO DETAILS HAVE BEEN PROVIDED REGARDING THE CONFIGURATION OR TO WHICH PORT(S) THE INFUSIONS WERE CONNECTED. THE PATIENT REQUIRED D50. THE DEVICES AND TUBING WERE NOT SEQUESTERED. NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233961 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 10010453 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PC UNIT, SN: UNK| ALARIS PUMP MODULE, SN:UNK| DUAL PORT CVL, MANUFACTURER/MODEL/LOT#: UNK| ALARIS PUMP MODULE ADMIN SET, 2426-0007, LOT#: UNK