BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE SET

    MDR report key: 7933468 · Received October 4, 2018

    Report

    Report Number
    7933468
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    July 18, 2018
    Report Date
    September 26, 2018
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NURSE SETTING UP PCA PUMP OBSERVED THAT THE TUBING SET WAS LEAKING FROM A PINHOLE LEAK IN THE TUBING NEAR A CONNECTION POINT. THE TUBING AND PACKAGING WAS SAVED AND A NEW PCA ADMINISTRATION KIT WAS USED SUCCESSFULLY TO SETUP THE PCA. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774290 ALARIS PCA MODULE SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. 10800175 17035480

    Patients

    Seq Age Sex Outcome Treatment
    1