BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3043438 · Received March 13, 2013

    Report

    Report Number
    9616066-2013-00162
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 15, 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
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SET HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WITH FAILURE INVESTIGATION RESULTS WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    NURSE REPORTED THAT TUBING LEAKED CHEMOTHERAPY RIGHT ABOVE THE IN-LINE FILTER. THE NURSE STATED THAT A TAXOL INFUSION WAS STARTED AND 30 MINUTES INTO THE INFUSION, THE DEVICE ALARMED FOR OCCLUSION. SHE CHECKED THE TUBING FOR KINKS AND OCCLUSIONS. WHEN SHE PICKED UP THE FILTER, THE TAXOL SQUIRTED ONTO THE WALL. SHE STATED IT WAS LEAKING FROM THE TUBING RIGHT ABOVE THE FILTER. NO CHEMOTHERAPY GOT ONTO HER OR THE PT. NO PT HARM OR MEDICAL INTERVENTION REQUIRED. PHARMACY STAFF CLEANED UP THE SPILL WITH A CHEMOTHERAPY SPILL KIT. NO ADD'L PT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106201 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 10010454 12085795

    Patients

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