BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® NON-VENTED BLOOD SET

    MDR report key: 5693000 · Received June 1, 2016

    Report

    Report Number
    9616066-2016-00722
    Event Type
    Malfunction
    Date Received
    June 1, 2016
    Date of Event
    May 5, 2016
    Report Date
    May 9, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K882302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S COMPLAINT THAT THE TUBING SEPARATED FROM THE SPIKE WAS CONFIRMED. VISUAL INSPECTION OBSERVED THAT THE PVC TUBING WAS SEPARATED FROM THE QUICK SPIKE. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE SEPARATION AT THE COMPONENT ENGAGEMENT. FLUID WAS LEAKING FROM THE SEPARATION. VISUAL INSPECTION UNDER MAGNIFICATION OBSERVED THAT BOTH SIDES OF THE PVC TUBING HAD NO SOLVENT APPLIED AT THE ENGAGEMENT. DIMENSIONAL ANALYSIS SHOWED THAT THE PVC TUBING WAS WITHIN SPECIFICATION. THE ROOT CAUSE OF THE SEPARATION WAS IDENTIFIED AS A MANUFACTURING ISSUE DUE TO NO SOLVENT BEING APPLIED AT THE JUNCTION OF THE PVC TUBING.

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SPIKE OF A BLOOD ADMINISTRATION SET SEPARATED FROM THE TUBING DURING A TRANSFUSION. THE SET WAS REPLACED AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346483 ALARIS® NON-VENTED BLOOD SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10010985 15117062

    Patients

    Seq Age Sex Outcome Treatment
    1