BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3043443 · Received March 13, 2013

    Report

    Report Number
    9616066-2013-00163
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 22, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORT OF A DISCONNECTION AT THE UPPER FITMENT WAS CONFIRMED BY THE PICTURE PROVIDED BY THE CUSTOMER. UNABLE TO DETERMINE THE CAUSE OF THE DISCONNECTION BECAUSE THE SET HAD BEEN DISCARDED BY THE CUSTOMER. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DURING A CHEMO INFUSION, A NURSE WAS TRYING TO GET BUBBLES OUT OF THE PUMPING SEGMENT AND THE TUBING DISCONNECTED AT THE UPPER FITMENT, RESULTING IN A CHEMO SPILL. NO PT OR STAFF HARM. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106386 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 10015048 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS PUMP MODULE, SN UNKNOWN| ALARIS PC UNIT, SN UNKNOWN