BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 4792479 · Received May 22, 2015

    Report

    Report Number
    9616066-2015-00675
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    February 16, 2015
    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

    NO PRODUCT WILL BE RETURNED. NO INVESTIGATION WAS PERFORMED.THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE 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. DUE TO THE RESULTANT LEAK IT WAS ESTIMATED THAT THE PATIENT WAS NOT RECEIVING HIS INFUSION FOR 30 MINUTES. THE INFUSION WAS RESUMED AND THE RATE WAS INCREASED TO COMPENSATE. IT WAS ESTIMATED THAT LESS THAN 2 ML OF CHEMOTHERAPY WAS SPILLED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336465 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 11607787

    Patients

    Seq Age Sex Outcome Treatment
    1