BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    MDR report key: 3063235 · Received March 27, 2013

    Report

    Report Number
    9616066-2013-00212
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 5, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 03/27/2013. INTERNAL FILE NO: (B)(4). PT'S INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED. UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED LEAK. ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. A F/U REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS SHOULD THE DEVICE BE RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TUBING LEAKED CHEMOTHERAPY (ETOPOSIDE) OUT OF THE TOP OF THE SILICONE SEGMENT AFTER BEING CONNECTED TO THE PATIENT AND PLACED INTO THE PUMP. THE LEAK WAS NOTED WHEN THE NURSE STARTED THE PROGRAMMING. THE NURSE STATED THAT THE TUBING WAS PRIMED BY THE PHARMACY THEN SENT TO THE FLOOR IN A BAG. THE NURSE REPORTED THAT NOT VERY MUCH MEDICATION LEAKED AND THE CHEMOTHERAPY SPILL WAS CLEANED UP WITHOUT ANY PROBLEMS. THE NURSE RECEIVED NEW MEDICATION AND RESTARTED THE INFUSION WITHOUT ANY ISSUES. NO MEDICATION GOT ON THE NURSE OR THE PT AND NO PT HARM OR MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER STATED THAT NO ADD'L PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127311 ALARIS PUMP MODULE IV ADMINISTRATION SET FPA CAREFUSION CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK