BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVASCULAR ADMINISTRATION SET

    MDR report key: 6137127 · Received November 30, 2016

    Report

    Report Number
    1723533-2016-00176
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 28, 2016
    Manufacturer
    WALKMED INFUSION, LLC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE PATIENT OBSERVED MEDICATION WAS LEAKING, THEY CALLED THEIR CLINIC. THE CLINICIAN INSTRUCTED THE PATIENT TO CLAMP THE ADMINISTRATION SET AND STOP THE PUMP. THE PATIENT CAME TO THE CLINIC AND A WHITE FILM WAS OBSERVED ON THE PUMP'S CARRYING CASE, THE PATIENT'S CLOTHES, AND THE INFUSION PUMP. THE PATIENT DID NOT SUSTAIN ANY INJURY, AND THEY WERE INSTRUCTED TO WASH THEIR CLOTHES AND ANY EXPOSED SKIN. THE CLINICIAN DID NOT OBSERVE ANY PHYSICAL DEFECTS IN THE PRODUCT IN QUESTION. THE DEVICE IN QUESTION WAS NOT RETURNED TO WALKMED INFUSION; THEREFORE, A PRODUCT EVALUATION COULD NOT BE PERFORMED. THE CATALOG AND LOT NUMBERS WERE NOT PROVIDED; THEREFORE, WALKMED INFUSION COULD NOT PERFORM A MANUFACTURING REVIEW. DEVICE DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    DURING TREATMENT, A MEDICATION LEAK WAS OBSERVED AT THE CONNECTION SITE BETWEEN THE MEDICATION BAG AND THE ADMINISTRATION SET. THE PATIENT WAS EXPOSED TO THE LEAK MEDICATION, BUT DID NOT SUSTAIN ANY INJURIES. THE PATIENT WAS INSTRUCTED TO WASH THEIR CLOTHES AND ANY EXPOSED SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788030 INTRAVASCULAR ADMINISTRATION SET FPA WALKMED INFUSION, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other WALKMED INFUSION 350VL INFUSION PUMP