BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 4791483 · Received May 22, 2015

    Report

    Report Number
    9616066-2015-00664
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    December 2, 2014
    Report Date
    April 10, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT SEQUESTERED BY THE CUSTOMER. NO FAILURE INVESTIGATION COULD BE PERFORMED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED.

    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. THE DISCONNECTION WAS DISCOVERED AT THE END OF A PLATELET TRANSFUSION AS THE PATIENT'S SHIRT WAS NOTED TO BE WET NEAR THE NEEDLELESS PORT. THE IV TUBING WAS DISCARDED. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333932 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 11607787

    Patients

    Seq Age Sex Outcome Treatment
    1