BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2961048 · Received January 16, 2013

    Report

    Report Number
    9616066-2013-00015
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORT OF CHEMO LEAKING FROM THE SET COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS DISCARDED BY THE CUSTOMER DUE TO CHEMO CONTAMINATION AND NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CHEMO LEAKED FROM THE IV SET WHILE INFUSING ON A PATIENT. NO PATIENT OR STAFF HARM REPORTED. THE LOCATION OF THE LEAK ON THE SET WAS NOT PROVIDED. THE SET WAS DISCARDED BECAUSE OF CHEMO CONTAMINATION. CUSTOMER STATED THAT NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24111 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 11532269 12046537

    Patients

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