BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 4791709 · Received May 22, 2015

    Report

    Report Number
    9616066-2015-00667
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    December 30, 2014
    Report Date
    April 10, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED. NO INVESTIGATION WAS PERFORMED. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PRIMARY SET IV LINE SPONTANEOUSLY DISCONNECTED AT THE DISTAL END LUER CONNECTION TO A NON-CAREFUSION NEEDLELESS VALVE DURING AN ETOPOSIDE INFUSION. THE MEDICINE BAG & IV TUBING WERE DISCARDED AND THE "POST-HYDRATION" INFUSION WAS RESTARTED. THERE WAS 51 MLS OF ETOPOSIDE DRUG REMAINING FROM THE DISCONNECTED INFUSION, WHICH WAS ORDERED FOR ADMINISTRATION ONCE PHARMACY MIXED A NEW BAG. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336991 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1