BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 5100799 · Received September 24, 2015

    Report

    Report Number
    9616066-2015-01173
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 4, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K894842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S COMPLAINT OF TUBING LEAKING WAS CONFIRMED. VISUAL INSPECTION NOTED THAT THE VINYL TUBING WAS COMPLETELY SEPARATED FROM THE DRIP CHAMBER BLOOD SET OUTLET PORT. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE TUBING BEING SEPARATED AT THE COMPONENT ENGAGEMENT. FLUID WAS LEAKING FROM THE SEPARATION. VISUAL INSPECTION UNDER A MICROSCOPE NOTED THAT BOTH SIDES OF THE VINYL TUBING HAD INSUFFICIENT SOLVENT APPLIED AT THE ENGAGEMENT. THE ROOT CAUSE OF THE TUBING LEAKING WAS IDENTIFIED AS A MANUFACTURING ISSUE DUE TO INSUFFICIENT SOLVENT BEING APPLIED AT THE JUNCTION OF THE VINYL TUBING.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT WAS RECEIVING FRESH FROZEN PLASMA AND NOTICED THE PLASMA WAS LEAKING ON THE FLOOR. UPON INSPECTION BY THE NURSE SHE NOTICED THE TUBING WAS SEPARATED AT THE UPPER DRIP CHAMBER. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630286 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10062818

    Patients

    Seq Age Sex Outcome Treatment
    1