BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 5248219 · Received November 24, 2015

    Report

    Report Number
    9616066-2015-01614
    Event Type
    Malfunction
    Date Received
    November 24, 2015
    Date of Event
    May 24, 2015
    Report Date
    November 3, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A DISCONNECTION WAS NOT CONFIRMED. VISUAL INSPECTION OF THE SET¿S COMPONENTS NOTED NO SEPARATIONS, DAMAGES, OR ANY ISSUES. ALTHOUGH THE MATING COMPONENT USED DURING THE REPORTED EVENT WAS NOT RECEIVED, FUNCTIONAL TESTING PERFORMED ON THE RECEIVED SUSPECT SET USING A LAB MATING COMPONENT WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF A DISCONNECTION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PRIMARY IV TUBING HAD BECOME DISCONNECTED FROM THE PATIENT'S PICC SINCE IT WAS LAST CHECKED AN HOUR EARLIER, RESULTING IN LEAKAGE OF IV FLUID. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776923 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2122-0007

    Patients

    Seq Age Sex Outcome Treatment
    1